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Search Results Within Category "Cancer"

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Suggestions within category "Cancer"

166 Study Matches

MT2015-29 : Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Adult Unrelated Donor for the Treatment of Hematological Disorders

The primary research element is to determine whether a graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide, tacrolimus and MMF will reduce the likelihood of chronic GVHD in patients receiving a standard hematopoietic myeloablative stem cell transplant. The treatment related components of this protocol are established clinical practices. We are looking at cumulative incidence of chronic GVHD requiring systemic immunosuppressive treatment at 1 year post-transplant.

Principal Investigator: Punita Grover
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001087
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• no more than 60 years old
• may be unable to work; able to live at home and care for self
• women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria (differ by diagnosis)
Exclusion Criteria:

• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• active central nervous system cancer
• active HIV infection or known HIV positive serology
• active uncontrolled infection
• women who are pregnant or breast feeding
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Leukemia, Acute Myeloid Leukemia, ALL, AML, HSCT
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NRG-BN013: Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) versus Fractionated SRS (FSRS) for Intact Brain Metastases

We are doing this study to compare the effectiveness of Single Fraction Stereotactic Radiosurgery (SRS) to radiation treatment called fractionated SRS (or FSRS). SRS delivers a high dose of radiation in a single treatment to the small areas of cancer in the brain. FSRS that delivers a high dose of radiation given over 3 treatments. Both SRS and FSRS only deliver radiation to the small areas of cancer in the brain and minimizes dose to the surrounding normal brain tissue.

Principal Investigator: Lindsey Sloan
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026403
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of one of the following solid tumor malignancies within 5 years prior to registration: non-small cell lung cancer (NSLS), melanoma, breast cancer, renal cell cancer, gastrointestinal cancer
• no prior radiotherapy to the brain
• see link to clinicaltrials.gov for complete inclusion criteria
Conditions: Cancer
Keywords: Brain Metastases
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A Randomized, Controlled, Multicenter, Phase 3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination with Nivolumab Versus Treatment of Physician s Choice in Patients with Advanced Melanoma That Has Progressed on an Anti-PD-1 and an Anti-CTLA-4 Containing Treatment Regimen [IGNYTE-3]

The purpose of this research is to compare the effects of nivolumab with vusolimogene oderparepvec (VO) against standard of care treatment drug(s) currently available for patients with advanced melanoma. We expect that taking part in this research will last up to 60 months.

Principal Investigator: Benjamin Manning
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023233
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 12 years old
• confirmed metastatic Stage IIIb through IV/M1a through M1d cutaneous melanoma that cannot be surgically removed
• disease progression (PD) on an approved anti-PD-1 and an anti-CTLA-4 treatment, administered either as a combination regimen (eg, nivolumab + ipilimumab) or in sequence for at least 8 weeks
• documented BRAF V600 mutation status
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• more than 2 lines of systemic therapy for advanced melanoma
• known acute or chronic hepatitis
• known human immunodeficiency virus (HIV) infection
• prior cancer in the previous 3 years, except for locally curable cancers that have apparently been cured
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Advanced Melanoma, Melanoma
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MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy

This study will test GTB-5550, a B7H3-targeted natural killer (NK) cell engager, for the treatment of select solid tumor cancers. The study will determine the optimal dose level and evaluate preliminary safety and efficacy.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027558
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed cancer that can be measured on scans
• fully active, able to care for yourself
• have recovered from side effects of any prior cancer treatments
• have adequate blood counts, kidney, liver, heart, and lung function based on recent lab tests
• see link to clinical trials.gov for complete Inclusion criteria
Exclusion Criteria:

• recent cancer treatment (within 2 weeks)
• have had a prior organ transplant
• are pregnant or breastfeeding
• another active or recent cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), solid tumor cancer
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A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors

This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.

Principal Investigator: Emmanuel Antonarakis
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024172
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Cancer
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HM2023-43: A phase 2 trial of tafasitamab in combination with lenalidomide+rituximab in treatment-naive follicular lymphoma and marginal zone lymphoma

This study is to see if patients who get tafasitamab in addition to the standard regimen of lenalidomide and rituximab when they are just starting treatment are more likely to stay in remission after treatment than those who do not. We expect that participants will be in this research study for approximately 3 years total. Patients will be on active treatment for approximately 1 year.

Principal Investigator: Sanjal Desai
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023899
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed marginal zone lymphoma
• have not received systemic therapy for lymphoma
• need treatment because of bulky disease, associated symptoms, or causing problems with vital organs (heart, spleen, lung)
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active HIV, Hepatitis B, Hepatitis C
• prior history of lenalidomide use
• history of another cancer in the past 5 years
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Follicular Lymphoma
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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF INAVOLISIB PLUS A CDK4/6 INHIBITOR AND LETROZOLE VERSUS PLACEBO PLUS A CDK4/6 INHIBITOR AND LETROZOLE IN PATIENTS WITH ENDOCRINE-SENSITIVE PIK3CA-MUTATED, HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER (WO45654) (INAVO123)

The purpose of this research is to test safety, efficacy and compare the effects of a combination therapy involving inavolisib plus a CDK4/6i (palbociclib) and letrozole versus placebo plus a CDK4/6i (palbociclib) and letrozole on patients with HR+, HER2- advanced breast cancer (ABC). In this study, you will get either inavolisib plus palbociclib and letrozole or placebo plus palbociclib and letrozole. A placebo looks like a drug but has no active ingredient.

Principal Investigator: Douglas Yee, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025543
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• women or men with confirmed metastatic breast cancer
• ER-positive and/or progesterone receptor-positive and HER2-negative tumor and mutation in PI3K Gene
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant, breastfeeding, or intend to become pregnant
• metaplastic breast cancer
• Type 2 diabetes requiring ongoing treatment; or any history of Type 1 diabetes
• inflammatory or infectious conditions in either eye
• active lung disease
• history of or active inflammatory bowel disease
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), breast cancer
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HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027

Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.

Principal Investigator: Veronika Bachanova, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00001341
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
Exclusion Criteria:

• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Hodgkin Lymphoma
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An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection

We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.

Principal Investigator: Cyrus Jahansouz
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00019579
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Digestive & Liver Health
Keywords: c-diff, Clinics and Surgery Center (CSC), colon cancer, colon surgery, gut health, microbiota transplant
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A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

The purpose of this study is to assess whether JNJ-87189401 given in combination with pasritamig (JNJ-78278343) to men with metastatic castration-resistant prostate cancer (also known as mCRPC) can cause side effects, and to find doses for the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and pasritamig stay in the body, how they act on the body, and how the body responds to them.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027319
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted
• Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist)
• fully active, able to carry on all pre-disease performance without restriction or unable to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinical trials.gov for complete Inclusion criteria
Exclusion Criteria:

• active autoimmune disease in the 12 months that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
• any of the following within past 6 months: myocardial infarction, severe or unstable angina, significant ventricular arrhythmias, congestive heart failure, transient ischemic attack (TIA), or Cerebrovascular accident (CVA, stroke)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), mCRPC, Prostate cancer
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MT2024-13: First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma

The upfront treatment for astrocytoma is surgery, radiation therapy, and chemotherapy. There is currently no standard therapy for when the astrocytoma has returned (recurs) or re-grows (progresses). This study uses the investigational drug FT536, a cell therapy that stimulates the immune system into action to treat astrocytoma that has returned or regrown. FT536 is a type of cell therapy made up of “natural killer” or NK cells, a type of immune blood cell that are known to attack cancer cells. The primary purpose of this study is to identify a safe dose of FT536 cells when given as an intratumoral injection and to identify the side effects of treatment with FT536. Another purpose of this study is to understand how FT536 alters the immune system in the brain and body.

Principal Investigator: Elizabeth Neil
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027280
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 75 years old
• confirmed Grade 4 astrocytoma that has reoccurred or progressed
• completed usual antitumor treatment including surgery, radiation therapy, and temozolomide with or without Optune/ Tumor Treatment Fields (TTF)
• able to have MRI scans with contrast agent
• completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function when starting the study
• must use a highly effective form of birth control from the first study visit until at least 3 months after the dose of FT536
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• prior treatment with bevacizumab or any other cellular therapy
• prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy
• women who are pregnant or breastfeeding
• history of another cancer in the past 5 years
• other significant medical or social conditions that would limit the ability to complete the study requirements
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Astrocytoma, Brain Cancer
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A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer (KLK2-comPAS)

The purpose of this study is to understand if a new immune treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone for patients without other treatment options.

Principal Investigator: Nicholas Zorko
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026133
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Sex: Male
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• exhausted all approved therapies or no additional treatments recommended or tolerable
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications or more than 10 mg of prednisone daily
• significant lung disease (2 liters of oxygen or more)
• another cancer
• heart disease in the past six months (heart attack, stroke, or heart failure)
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), mCRPC, metastatic castration-resistant prostate cancer
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MT2025-36: Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)

This study is about treatment of Melanoma (a kind of skin cancer) that has spread or cannot be surgically removed and has gotten worse after standard treatments. This study includes patients with melanoma from any part of the body except the eye. The main purpose of this study is to learn if the study medicine (tebentafusp), alone or a combination with pembrolizumab, helps patients with advanced melanoma live longer. The combination of pembrolizumab and tebentafusp used in this study is experimental.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001926
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• unresectable Stage III or Stage IV non-ocular melanoma
• may not be able to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding
• diagnosis of ocular or metastatic uveal melanoma
• history of a another type of cancer
• unable to be retreated with pembrolizumab because of a previous severe side effect
• significant pulmonary or cardiac disease or impaired lung or cardiac function
• known psychiatric or substance abuse disorders
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: melanoma, Clinics and Surgery Center (CSC)
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PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA

The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.

Principal Investigator: Frank Ondrey
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001771
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: Clinics and Surgery Center (CSC), Oral Leukoplakia
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A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.

Principal Investigator: Rahel Ghebre, Dr
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: MMCORC048
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
Exclusion Criteria:

• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Conditions: Cancer
Keywords: Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma
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A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)

The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.

Principal Investigator: Britt Erickson
Age Group: 35 years to 50 years old
This study is NOT accepting healthy volunteers
IRB Number: SITE00001183
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Sex: Female
Age Group: 35 years to 50 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
Exclusion Criteria:

• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
Conditions: Cancer, Women's Health
Keywords: Clinics and Surgery Center (CSC), BRCA1, Ovarian Cancer
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A Randomized Double Blind Phase II Trial of Restorative Microbiota Therapy (RMT) or Placebo in Combination with Durvalumab (MEDI4736) and Tremelimumab With Chemotherapy in Treatment Naïve Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer

The investigational therapy in this study is referred to as Restorative Microbiota Therapy (RMT). It is prepared by extracting healthy bacteria from the stool of healthy human donors and making it into capsules taken by mouth. The donor stool samples are rigorously tested for harmful bacteria and viruses before processing. There is scientific evidence to suggest that RMT might make immunotherapy more effective. The primary goal of the study is to test if RMT makes durvalumab + tremelimumab treatment with chemotherapy more effective to control lung cancer.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00007800
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed adenocarcinoma of the lung that is stage IIIB/C or stage IV that can't be surgically removed
• prior chemotherapy or immunotherapy as adjuvant therapy for lung cancer is permitted as long as it has been more than 6 months from last dose
• people who have treated brain metastasis are eligible as long as they have stable symptoms, are more than 2 weeks from completion of therapy, and do not require more than 10mg of daily prednisone or equivalent
• restricted in strenuous physical activity but can walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• weigh at least 30 kg (66 lbs.)
• contact study staff for additional requirements
Exclusion Criteria:

• women who are pregnant or breast feeding
• unable to swallow medications
• additional medical and mental health diagnosis (study staff will review)
Conditions: Cancer, Respiratory System
Keywords: Clinics and Surgery Center (CSC), Adenocarcinoma of Lung, Lung Cancer
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National Liver Cancer Screening Trial (TRACER)

Finding liver cancer early is important to increase chances of getting treatment and decreasing risk of dying from cancer. The purpose of this research is to compare the effectiveness of two liver cancer screening methods to detect liver cancer at an early stage. Participants will be randomly (by chance) placed in one of two study groups – one group will undergo ultrasound imaging of the liver with or without a blood test to measure a specific protein, whereas the second group will undergo a blood test for liver cancer screening called a GALAD score. The GALAD score combines three blood tests to screen for liver cancer. We do not currently know if GALAD would help detect liver cancer earlier than standard screening.

Principal Investigator: Elizabeth Aby
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00023768
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 18 to 85 years old
• diagnosis of cirrhosis of the liver of any cause, or Hepatitis B
• physician has determined patient is eligible for for hepatocellular carcinoma (HCC) screening
Exclusion Criteria:

• history of liver cancer or clinical symptoms of liver cancer
• presence of another active cancer besides skin cancer
• history of organ transplant
• active listing for liver transplant
• history of alcohol related liver inflammation within 3 months
• known pregnancy at the time of consent
• active warfarin use
Conditions: Cancer
Keywords: HCC, hepatocellular carcinoma, Liver Cancer, Clinics and Surgery Center (CSC)
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A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination with the CDK4/6 Inhibitor Ribociclib, with the PI3K Inhibitor Alpelisib, or with the mTOR inhibitor Everolimus in Adult Subjects with Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

The main purpose of this study is to look at how safe and well tolerated the study drug is in combination with ribociclib (Group 1) or alpelisib (Group 2), the levels of the study drug and ribociclib or alpelisib in your blood, and how your body and your cancer respond.

Principal Investigator: David Potter
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: SITE00001932
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 18 years old
• diagnosis of advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
• received no more than 2 prior hormonal regimens for advanced or metastatic disease
• received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer
Exclusion Criteria:

• significant heart disease
• cerebral vascular disease within 6 months
• pulmonary embolism, or deep venous thrombosis within the last 6 months
• pneumonitis or interstitial lung disease
• history or ongoing gastrointestinal disorders that result in poor absorption of medications
• history of significant liver disease
• study staff will review medical history
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), alpelisib, HER2-neg breast cancer, HR-positive Breast Cancer, Metastatic Breast cancer, ribociclib
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Cell free and circulating tumor DNA in the management of muscle invasive bladder cancer, a prospective cohort study.

The goal of this study is to identify the role of cell-free fragments of DNA (cfDNA) and circulating tumor DNA (ctDNA) found in blood and/or urine of patients with bladder cancer in determining whether some patients can avoid chemotherapy and or radical cystectomy. Large numbers of samples need to be analyzed. Participants will be asked to provide additional blood and urine samples; no treatment is provided in this study.

Principal Investigator: Hamed Ahmadi
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026036
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• people who may have invasive bladder cancer
• planning to have a transurethral resection of bladder tumor (TURBT)
Exclusion Criteria:

• women who are pregnant
• any other active cancer
• at least able to do self care, up and walking & carry out light work or sedentary activity
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Bladder Cancer, TURBT
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COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Principal Investigator: Robin Williams
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00000151
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
Conditions: Cancer
Keywords: childhood cancer
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HM2024-29: Phase I/II Clinical Trial of Proteasome Inhibitor in Combination with CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML).

This study is meant for participants who have been diagnosed with acute myeloid leukemia (AML) and have a specific mutation in a gene called TP53. The study will give these participants an investigational drug called bortezomib in combination with an approved drug for AML, CPX-351 (brand name: Vyxeos). The researchers are studying this combination to find out if it is safe to give to people, as well as to find out how well it works for people who have AML with the TP53 mutation.

Principal Investigator: Joseph Norton
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024980
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• have not received any systemic chemotherapy for the treatment of AML
• able to care for self but may be unable to carry on normal activity or to do active work
• sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active central nervous system malignancy or symptoms of CNS involvement
• cardiac disease including congestive heart failure with symptoms, heart attack (myocardial infarction) in the past 6 months, serious arrhythmia, unstable angina
• women who are pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Blood Disorders, Cancer
Keywords: Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US). Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. Participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Principal Investigator: Sharon Allen, PhD
Age Group: 18 years and over
This study is also accepting healthy volunteers
IRB Number: STUDY00020047
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Sex: Female
Age Group: 18 years and over
This study is also accepting healthy volunteers
Inclusion Criteria:

• 18 to 45 years old
• uncomplicated pregnancy at gestational week 30 or beyond, or birth of a child within the past 6 months
• history of ≥ 4 cigarettes per month during the six months prior to pregnancy
• motivation to become and/or stop smoking after delivery
• willing to use birth control for the 12 weeks of the study
• live in the continental US and have a device to connect to the internet for participation
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
• major depressive disorder
• current or within the past 3 months treatment for drug or alcohol use
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer, Community Health
Keywords: post partum, smoking
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HM2025-16: Phase Ib/II Trial of Epcoritamab plus Ibrutinib in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma.

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory).

Principal Investigator: Marie Hu
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026284
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of B-cell non-Hodgkin lymphoma
• have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody
• treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days
• capable of all selfcare and able to walk but unable to carry out any work activities; up and about more than 50% of waking hours
• women of child-bearing potential and men must agree to use adequate contraception 2 weeks before starting treatment, for the duration of study participation and for 12 months after completing treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• active central nervous system (CNS) involvement
• active uncontrolled infection
• current uncontrolled or symptomatic cardiovascular conditions
• liver cirrhosis with moderate to severe liver impairment
• significant lung disease
• treatment with coumadin/warfarin
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), B-cell non-Hodgkin lymphoma, Lymphoma
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DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)

The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00026413
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• may not be able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Endometrial Cancer
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MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.

Principal Investigator: Benjamin Manning
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00022060
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Metastatic Non Small Cell Lung Cancer, NSCLC
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A Phase Ib open label randomised clinical trial to evaluate safety and efficacy of BI 770371 in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

The goal of this study is to find out whether combining different study drugs makes tumors shrink in people with advanced head and neck cancer. This type of cancer is in the mouth, nose, throat, and sinuses. The study drugs are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 1 out of 3 groups, by chance (like drawing names from a hat), and which of the study treatments participants will receive.

Principal Investigator: Manish Patel
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00024665
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• confirmed metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) of the primary tumor location of oral cavity, oropharynx, hypopharynx, and larynx
• have not received prior systemic treatment for metastatic or recurrent HNSCC
• do not have contraindications to pembrolizumab
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• Nasopharyngeal cancer (NPC)
• progressive HNSCC within 6 months of completion of systemic therapy
• prior allogeneic stem cell or solid organ transplantation
• see link to clinicaltrials.gov for complete Exclusion critieria
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), Head and Neck Squamous Cell Carcinoma, HNSCC
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IMPACT: A Clinical Investigation on IMproving Peripheral Neuropathy Induced by Anti-Cancer Drugs with Advanced Compression Technology; A Safety and Efficacy Study (IMPACT)

The purpose of this study is to evaluate the effectiveness of investigational devices (the Lilac Glove and Lilac Boot devices) for the temporary reduction of moderate to severe symptoms of peripheral neuropathy caused by chemotherapy during the treatment of cancer. The Lilac Glove and Lilac Boot devices are designed to keep chemotherapy medication from damaging nerves. The study involves wearing the Lilac Glove and Boot devices on both hands and feet at each treatment session. Participants will be randomly assigned (like the flip of a coin) into one of two treatment groups; the “intervention group” (which means you receive treatment with the therapeutic Lilac devices) or the “control group” (which means you will receive treatment with the sham devices).

Principal Investigator: Melissa Geller, MD
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00027329
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Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed solid tumor cancer, who will receive neo-adjuvant or adjuvant chemotherapy
• planned IV treatment with at least 4 cycles of chemotherapy, with no planned treatment pause for surgery
• willing to wear the Lilac Glove and Boot devices for the prescribed duration (devices to be fitted before infusion, and worn during infusion and for up to one (1) hours post infusion
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• baseline peripheral neuropathy of any kind
• chemotherapy in the previous 1 year
• any open wounds, sores, cysts or injury on the hands or on part of the upper arm where the device will be applied or on the feet or part of the lower leg where the device will be applied that may not be healed before chemotherapy starts
• untreated or uncontrolled hypertension
• poorly controlled diabetes
• weight greater than 140 kg (308 pounds)
• see link to clinicaltrials.gov for complete exclusion criteria
Conditions: Cancer
Keywords: Neuropathy, cancer, chemotherapy, Clinics and Surgery Center (CSC)
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A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak® in Recurrent or Metastatic Cervical Cancer

The purpose of this study is to learn more about ocular (relating to the eye) side-effects of tisotumab vedotin (brand name: TIVDAK™). A side effect is anything the drug does to your body besides treating your disease. It is approved for women with cervical cancer that has spread through the body or come back during or after chemotherapy. We are doing a study to understand whether there are any ocular side-effects of TIVDAK.

Principal Investigator: Deanna Teoh
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
IRB Number: STUDY00025592
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Sex: Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• cervical cancer that has returned (recurrent) or spread to other parts of the body (metastasized) during or after chemotherapy
• doctor has decided that Tivdak® is an option for treatment
• agree to use effective contraception
Exclusion Criteria:

• active eye disease
• women who are breastfeeding, pregnant, or planning to become pregnant
Conditions: Cancer
Keywords: Clinics and Surgery Center (CSC), cervical cancer
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ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Principal Investigator: Peter Gordon
Age Group: Not specified
This study is NOT accepting healthy volunteers
IRB Number: SITE00001628
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Sex: Male or Female
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
Exclusion Criteria:

• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
Conditions: Cancer, Cancer
Keywords: Acute Myeloid Leukemia, AML
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