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Suggestions within category "Cancer"

105 Study Matches

Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR (VAPOR 2)

The purpose of this study is to determine the safety and efficacy of the Vanquish System treatment in men who have intermediate risk prostate cancer. In this study, the Vanquish System will be used to destroy cancerous tissue in the prostate. After treatment, participants will undergo tests that will assess presence of prostate cancer.

Christopher Warlick, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019145
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Inclusion Criteria:

• 50 years or older
• PSA no more than 15 ng/ml
• cancer stage less than or equal to T2c
• had a multiparametric MRI within the last 12 months and MRI software guided fusion biopsy of the prostate within the last 6 months
Exclusion Criteria:

• prior surgery, intervention, or minimally invasive therapy, for the prostate cancer or bladder neck
• taking medications that have hormonal effects on the prostate or PSA or or testosterone supplement
• significant medical or mental health diagnosis (study staff will review)
Cancer, Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Prostate Cancer, Prostate Cancer
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MT2023-16: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer

This study will test TAK-186, an antibody that selectively targets EGRF-expressing tumor cells, to see if TAK-186 is safe in patients with unresectable, locally advanced or metastatic cancer.

Heather Beckwith
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019459
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Inclusion Criteria:

• unresectable, locally advanced or metastatic solid tumors are considered to express epidermal growth factor receptor (EGFR)
• willing to have new biopsy(s) for the study if it is possible
• able to care for self and do light work
• women of childbearing potential must be willing to use 2 forms of contraception throughout the study, starting at screening through 90 days after the last dose of TAK-186
• Males with partners of childbearing potential must use barrier contraception during the entire study treatment period through 120 days after the last dose of study drug and must not donate sperm during this period. Must also have partner use 2 forms of contraception (see above requirement)
• contact study staff for additional study requirements
Exclusion Criteria:

• history of known autoimmune disease with some exceptions
• major surgery or traumatic injury within 8 weeks before first dose of study drug
• unhealed wounds from surgery or injury
• serious underlying medical or psychiatric condition that would impair the ability of the participant to consent, receive or tolerate the planned treatment (study staff will review)
• women who are pregnant or breast feeding
Cancer
Clinics and Surgery Center (CSC), Colorectal Cancer, Non-small Cell Lung Cancer (NSCLC), Squamous Cell Cancer of Head and Neck (SCCHN)
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App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients Aim 3 Usability

This study will enroll individuals with cancer to test a prototype mobile application which will measure and summarize the time spent on cancer care related tasks.

Rachel Vogel
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020743
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Inclusion Criteria:

• at least 18 years old
• currently receiving treatment for any type of cancer
• able to read, write, and speak in English
• own an Android (version 9.0 or higher) or iOS smartphone (version 10.0 higher) or willing to use a smartphone that is provided
Cancer
cancer treatment
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MT2023-22: Phase 1/2 Study of IDP-023 as a Single Agent and in Combination with Antibody Therapies in Patients with Advanced Hematologic Cancers

There are 2 phases to this clinical research study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 is to find the recommended dose of the study drug IDP-023 that can be given alone (referred to as a “monotherapy”), with or without interleukin-2 (IL-2) and in combination with another anti-cancer drug, either daratumumab in subjects with relapsed/refractory MM or rituximab in subjects with relapsed/refractory NHL. The goal of Phase 2 is to learn if the recommended dose of IDP-023 found in Phase 1 with or without IL-2 can help to control advanced MM or NHL when given in combination with daratumumab or rituximab, respectively.

Aimee Merino
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019972
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Inclusion Criteria:

• diagnosis of Multiple Myeloma (MM) that has relapsed or is refractory disease after 3 or more prior lines of therapy
• OR Non-Hodgkin Lymphoma (NHL) that has relapsed or is refractory after 2 or more lines of chemotherapy
• restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
Exclusion Criteria:

• significant cardiac disease
• Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
• untreated central nervous system, epidural tumor metastasis, or brain metastasis
Cancer
Clinics and Surgery Center (CSC), MM, Multiple Myeloma, NHL, Refractory Multiple Myeloma, Refractory Non-Hodgkin Lymphoma
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Can spectral power and coherence reflect the integrity of the efferent cerebellar cortical pathway in cerebellar mutism syndrome?

This study will be measuring brain activity using EEG and assessing motor skills and speech in children following cancerous brain tumor resection. No direct cancer treatments or objectives are being targeted.

Sharyl Samagia-Grivette
Not specified
This study is also accepting healthy volunteers
STUDY00019602
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Inclusion Criteria:

• Cerebellar Mutism Syndrome (CMS) & Comparison (without CMS) Groups: ages 10 years 0 months to 25 years 11 months of age & fluent in English (parents/guardian do not need to be fluent in English)
• For those with Cerebellar Mutism Syndrome (CMS): history of resection of posterior fossa tumor at least 2 years before starting the study and at least 3 months post chemotherapy and radiation treatment
Exclusion Criteria:

• Comparison group without CMS: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder
• any genetic condition
• any neurologic condition including history of stroke, seizure disorder, or brain injury
• history of brain tumor or other cancer diagnosis
• CMS Group: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder prior to brain tumor diagnosis
• any genetic condition prior to brain tumor diagnosis
• any neurologic condition including history of stroke, seizure disorder, or brain injury disorder prior to brain tumor diagnosis
Brain & Nervous System, Cancer, Children's Health
brain tumor, cerebellar mutism syndrome (CMS)
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Phase 1/2 Study to Evaluate Palbociclib (IBRANCE) in Combination With Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients With Recurrent or Refractory Solid Tumors Protocol No.: ADVL1921/A5481092

This is a Phase 1/2 multicenter, open-label study to evaluate palbociclib in combination with either irinotecan (IRN) and temozolomide (TMZ) or topotecan (TOPO) and cyclophosphamide (CTX) chemotherapy in children, adolescents and young adults with recurrent or refractory solid tumors. The study consists of a non- randomized Phase 1 portion for recurrent or refractory solid tumors followed by potential non- randomized tumor specific cohort(s) and a randomized, Phase 2 portion for recurrent or refractory EWS.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
STUDY00007068
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Inclusion Criteria:

• 2 years to 20 years of age
• confirmed relapsed or refractory solid tumor (including CNS tumors but not lymphomas)
• recovered to CTCAE Grade 1 or less, or to baseline, from any non-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia
• serum/urine pregnancy test (for all girls 8 or older) negative at screening and at the baseline visit
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• prior irradiation to >50% of the bone marrow
• major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries
• patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days
• fertile male patients or female patients of childbearing potential who are unwilling or unable to follow contraceptive requirements
• pregnant or breastfeeding women
• additional exclusion criteria apply (study staff will review)
Cancer
Ewing Sarcoma, Medulloblastoma, Neuroblastoma, Rhabdoid Tumor, Rhabdomyosarcoma, Solid Tumors
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A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

This trial will evaluate other treatment options for high-risk NMIBC patients who were unresponsive to Bacillus Calmette Guerin (BCG therapy). We are studying two different drugs in combination with pembrolizumab. Participants will receive up to 35 doses of the trial drug and have tumor assessments for about 2 years. This will be followed by treatment tumor assessment for another 3 years for a total trial duration of 5 years.

Joseph Zabell
18 years and over
This study is NOT accepting healthy volunteers
1604M87002
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Inclusion Criteria:

• confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ) transitional cell carcinoma of the bladder
• tumor has been completely removed with bladder surgery
• BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy
• ineligible for radical cystectomy or refusal of radical cystectomy
• able to care for self, up and about for at least half of the day
• participants of child bearing age must be willing to use effective birth control
Exclusion Criteria:

• received intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT)
• active autoimmune disease that has required systemic treatment in the past 2 years
• active infection requiring systemic therapy
• pregnant or breast feeding
• contact study staff for additional study eligibility criteria
Cancer, Kidney, Prostate & Urinary
Clinics and Surgery Center (CSC), Bladder Cancer
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A Phase IB/II Multi-Cohort Study of Targeted Agents with Atezolizumab for Patients with Recurrent or Persistent Endometrial Cancer (EndoMAP)

The purpose of this study is to learn the effects, good or bad, of several possible study treatments for EndoCA that are selected based on genetic markers that can be found in these tumors.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001240
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Inclusion Criteria:

• recurrent or persistent endometrial carcinoma which has progressed or recurred after at least 1, but no more than 2, prior lines of therapy
Exclusion Criteria:

• primary invasive ovarian or cervical cancer occurring with this cancer
• other cancer occurring in the past 5 years
• active or history of autoimmune disease or immune deficiency
• history of cardiac, respiratory or neurological conditions (study staff will review)
Cancer, Women's Health
Clinics and Surgery Center (CSC), EndoCA, Endometrial Cancer
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MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies

The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.

Margaret MacMillan, MD
Not specified
This study is NOT accepting healthy volunteers
STUDY00016450
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Inclusion Criteria:

• hematological cancer needing stem cell transplant
• 60 years old or younger
Exclusion Criteria:

• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
Cancer
Hematologic Malignancy, Leukemia, Stem Cell Transplant, Clinics and Surgery Center (CSC)
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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.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00001341
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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)
Cancer
Clinics and Surgery Center (CSC), Hodgkin Lymphoma
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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.

Rahel Ghebre, Dr
18 years and over
This study is NOT accepting healthy volunteers
MMCORC048
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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
Cancer
Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma
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HM2022-48: A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia

This study is being performed to determine the safety and tolerability of ZN-c3 alone and the combination of ZN-c3 and ZN-d5 in Acute Myeloid Leukemia (AML). We want to identify the best doses of the study drugs and learn if either drug effects the blood levels of the other. We will also assess how effective the Study Drugs are in treating AML and explore whether certain aspects of AML can predict whether leukemia responds to the study drug(s).

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017682
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Inclusion Criteria:

• adults with Acute Myeloid Leukemia (AML) (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy
• able to walk and do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs
• men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs
Exclusion Criteria:

• active central nervous system (CNS) involvement
• significant cardiovascular disease
• active hepatitis B or hepatitis C infection
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Acute Myeloid Leukemia, AML
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COG AALL1731 - A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy)

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients (365 Days to 31 Years) with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000644
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Inclusion Criteria:

• Age: patients must be > 365 days and < 10 years of age (B-ALL patients without Down Syndrome-DS) OR no more than 31 years of age (B-ALL patients with DS) OR no more than 31 years of age (B-LLy patients with or without DS)
• Diagnosis: Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a BM aspirate; OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000 circulating leukemic cells;
• OR Patient has newly diagnosed B-cell LLy Murphy Stages I or II, with or without Down syndrome
• White Blood Cell Count (WBC) Criteria: B-ALL patients without DS must have an initial white blood cell count < 50,000
• B-ALL patients with DS are eligible regardless of the presenting WBC
Exclusion Criteria:

• Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
• Patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731
• Patients requiring radiation at diagnosis
• Female patients who are pregnant or breastfeeding their infants
Cancer, Children's Health
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Down Syndrome
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MT2020-27: Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to Tisagenlecleucel (Kymriah) Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

This purpose of this study is to identify a safe dose level for the study drug, E7777, when given with standard tisagenlecleucel therapy (also known by its brand name, Kymriah, is an immunotherapy that is made from the participants own blood cells) in participants with Diffuse Large B-Cell Lymphoma (DLBCL). Up to three dose levels of E7777 will be tested.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011895
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Inclusion Criteria:

• diagnosis of a relapse or refractory large B cell lymphoma, for which treatment with Kymriah is planned
• received two or more lines of systemic therapy
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of child bearing age must use birth control for 30 days following completion of treatment
• additional inclusion criteria (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• CNS involvement by malignancy
• eye disease or complaints visual acuity impairment, color or shape distortion, or blurred vision - potential participants are required to have an eye exam as part of screening
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Diffuse Large B Cell Lymphoma, DLBCL, High-grade B-cell Lymphoma
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A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease

The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.

Hamed Ahmadi
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019273
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Inclusion Criteria:

• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• women and men of child bearing age must follow specific requirements for birth control
Exclusion Criteria:

• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bladder Cancer in Situ (CIS), Bladder CIS
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An International, Phase 3, Randomized, Multicenter, Open label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) (INSIGHT)

This study is being done to learn how well ripretinib works against cancer as compared to sunitinib in patients with a specific GIST-gene mutation who have received imatinib. We will also learn more about the safety of ripretinib and look at how ripretinib may affect your body. The choice of whether you will be given ripretinib or sunitinib will be assigned by a computer, by chance, like the flip of a coin. You will have a 2 out of 3 chances of receiving ripretinib. You will know if you are receiving ripretinib or sunitinib.

Keith Skubitz, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001953
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Inclusion Criteria:

• diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample
• disease progression on imatinib treatment, confirmed by scan
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• participants of reproductive potential must agree to follow contraception requirements
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• known active central nervous system metastases
• heart disease, myocardial infarction within 6 months of starting the study, active ischemia or any other uncontrolled cardiac condition such as angina, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure
• Gastrointestinal abnormalities such as inability to take oral medication, malabsorption syndromes, requirement for intravenous alimentation
• additional exclusions apply malabsorption syndromes requirement for intravenous alimentation
Rare Diseases, Cancer
Clinics and Surgery Center (CSC), Advanced Gastrointestinal Stromal Tumor, GIST, Stomach Cancer
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MT2022-49: Early identification of cognitive side-effects of immunotherapy

This study is testing different ways to look for neurologic side effects in patients who get CAR-T therapy for their cancer.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019811
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Inclusion Criteria:

• planning to have inpatient CAR-T therapy for primary cancer
• fluent in English (written or spoken)
Exclusion Criteria:

• presence of speech or hearing problem
• diagnosis of cognitive impairment
Cancer
Clinics and Surgery Center (CSC), CAR-T, Chimeric Antigen Receptor T-Cell Therapy
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Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.

Colleen Correll
Not specified
This study is NOT accepting healthy volunteers
1506M74443
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Inclusion Criteria:

• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
Arthritis & Rheumatic Diseases, Cancer
juvenile idiopathic arthritis (JIA), pediatric rheumatic disease
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An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

One goal of this study is to find out if enfortumab vedotin is effective and safe as a treatment for people with breast, lung, head and neck, gastric, gastroesophageal junction, or esophageal cancer. Researchers will look at how enfortumab vedotin can act in the body. Enfortumab vedotin is expected to work by attacking cells that have a protein called Nectin-4, commonly found in cancer cells. Another goal of this study is to find out if enfortumab vedotin is effective and safe when combined with another US Food and Drug Administration (FDA) approved medicine, pembrolizumab (brand name KEYTRUDA®), and used as a treatment for people with head and neck cancer who have not received previous chemotherapy treatment other than the chemotherapy that may have been given in combination with radiation therapy or right before or right after surgery in the past.

Naomi Fujioka
18 years and over
This study is NOT accepting healthy volunteers
SITE00001051
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Inclusion Criteria:

• locally advanced or metastatic disease of breast, lung, head and neck, gastric, gastroesophageal junction, or esophagus, that is not amenable to curative intent treatment
• evidence of progression on or after the last regimen received
• restricted strenuous activity but able to walk carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for specific requirements by type of cancer
Exclusion Criteria:

• study staff will review
Cancer
Clinics and Surgery Center (CSC), Locally Advanced or Metastatic Malignant Solid Tumors, Metastatic Cancer
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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

The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone. Letrozole is a drug called an aromatase inhibitor, which indirectly stops the body from producing estrogen. The use of the hormonal therapy drug, letrozole without chemotherapy may shrink or stabilize your cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Half of women in this study will receive letrozole with paclitaxel/carboplatin and the other half will receive letrozole alone.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00002052
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Inclusion Criteria:

• newly diagnosed, stage II-IV low-grade serous ovarian cancer: Ovarian cancer includes ovarian, fallopian tube and primary peritoneal cancers
• must have undergone an attempt at maximal cytoreductive surgery and a bilateral salpingo-oophorectomy
• ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• surgery no more than eight weeks before starting the study
• able to take medications by mouth
• contact study staff for additional inclusion criteria
Exclusion Criteria:

• have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease
• received previous hormone therapy for the treatment of this disease
• history of severe cardiac disease
• central nervous system metastases
• active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection
• neuropathy causing more than moderate pain and affecting daily activity
Cancer, Women's Health
Fallopian Tube Serous Cancer, Ovarian Low Grade Serous Cancer, Peritoneal Serous Cancer, Clinics and Surgery Center (CSC)
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A randomized phase II trial of adjuvant Pembrolizumab versus observation following curative resection for stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153

This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone.

Amit Kulkarni
18 years and over
This study is NOT accepting healthy volunteers
STUDY00010745
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Inclusion Criteria:

• at least 18 years old
• diagnosis of non-small cell lung cancer (NSCLC)
• tumor size between 1 and 4 cm in size
• had a complete surgical resection of stage I NSCLC between 4-12 weeks ago
• able to walk and carry out basic activities of living
• women are willing to use highly effective birth control for 120 days after last dose of study drug
• certain laboratory values are required (study staff will review)
Exclusion Criteria:

• chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer
• active additional cancer that is progressing or has required treatment within the past 3 years
• diagnosis of immunodeficiency or receiving chronic steroid therapy
• women who are pregnant or breast feeding
• other active diseases (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lung Cancer, Lung Cancer, Non-small Cell Lung Cancer (NSCLC)
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Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia

The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001945
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Inclusion Criteria:

• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion Criteria:

• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Cancer
Clinics and Surgery Center (CSC), Endometrial Carcinoma, endometrial intraepithelial neoplasia (EIN)
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ARACOG: A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated with Darolutamide or Enzalutamide (ARACOG)

To compare the effects of treatment with enzalutamide (ENZ) versus darolutamide (DARO) on the cognitive function of men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC) by comparing the change in the maximally changed cognitive domain from baseline in patients in each study arm by 24 weeks.

Stuart Bloom
18 years and over
This study is NOT accepting healthy volunteers
SITE00000986
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Inclusion Criteria:

• confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• castration-resistant prostate cancer defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL, while on treatment
• testosterone level of <50 ng/dL
• able to walk and care for self, but unable to work
• able to read & speak English
• able to swallow study tablets whole
Exclusion Criteria:

• prior chemotherapy for treatment of CRPC. Men who received chemotherapy for castrate-sensitive prostate cancer are eligible provided chemotherapy was completed more than 6 months ago
• prior treatment with specific drugs (study staff will review)
• radiation treatment for more than 21 days during enrollment in the study
• neurological diseases that affect thinking (dementia, seizures, etc.)
• chronic use of opiates that affects thinking
• significant history of falls or risk of falls
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Prostate Cancer, CRPC, Metastatic Prostate Cancer, Prostate Cancer, Prostate Cancer
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COG ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

Christopher Moertel, MD
Not specified
This study is NOT accepting healthy volunteers
SITE00001839
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Inclusion Criteria:

• ages 2 to 21 at time of starting the study
• diagnosis of low-grade glioma or low-grade astrocytoma brain tumor
• tumor size increased or returned after treatment with at least one cancer therapy
• high blood pressure (hypertension) must be under control
• must be able to swallow whole capsules
• contact study staff for additional criteria
Exclusion Criteria:

• treatment for another tumor in the past year
• any serious medical or mental health diagnosis, including substance use disorders or ophthalmological conditions (study staff will review)
• women who are pregnant or breast feeding
Cancer
Astrocytoma, Glioma, Low Grade Astrocytoma, Low Grade Glioma
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MT2021-11: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

This research is being done to determine whether the investigational drug tabelecleucel (allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes [EBV-CTLs]) can help people with EBV-associated diseases.

Joseph Maakaron
Not specified
This study is NOT accepting healthy volunteers
STUDY00013494
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Inclusion Criteria:

• diagnosis of Epstein-Barr Virus (EBV) disorder
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.com for additional inclusion criteria
Exclusion Criteria:

• women who are breastfeeding or pregnant
• currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy
• serious known active infections
• additional exclusion criteria apply (study staff will review)
Cancer, Infectious Diseases
Clinics and Surgery Center (CSC), Epstein-Barr Virus (EBV)
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NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma

We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.

Britt Erickson
18 years and over
This study is NOT accepting healthy volunteers
SITE00001733
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Inclusion Criteria:

• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
Exclusion Criteria:

• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Cancer, Women's Health
endometrial carcinosarcoma, Endometrial Serous Adenocarcinoma, Clinics and Surgery Center (CSC)
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A Phase 1B and randomized phase 2 trial of megestrol acetate with or without ipatasertib in recurrent or metastatic endometrioid endometrial cancer

The study is divided into two portions. In the first phase, we want to test the safety of a drug called ipatasertib, by testing different doses of the drug to see which dose is safer for people when given in combination with a fixed dose of a drug called megestrol acetate (MA). In Phase II, we are studying how safe the treatment is and how well it works. We are doing this study because we want to find out if this approach is better or worse than the usual approach for endometrial cancer.

Deanna Teoh
18 years and over
This study is NOT accepting healthy volunteers
SITE00001947
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Inclusion Criteria:

• grade 1 or 2 endometrioid endometrial cancer that has returned or has spread to other parts of the body (metastatic)
• may have received unlimited prior lines of treatment
• able to walk, care for self, and active at least 50% of the day
• able to swallow oral medications
• contact study staff for additional requirements
Exclusion Criteria:

• prior treatment with an AKT inhibitor
• women who are pregnant or breast feeding
• other medical or mental health diseases (study staff will review)
Cancer, Women's Health
Endometrial Cancer, Metastatic Endometrial Cancer, Clinics and Surgery Center (CSC)
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A Randomized Phase II Study Comparing Sequential High dose Testosterone and Enzalutamide to Enzalutamide alone in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer

The goal of this current study is to test whether men with prostate cancer that is getting worse after treatment with hormone therapy and abiraterone respond better to alternating treatment with testosterone and enzalutamide vs. enzalutamide alone. We are testing to see which is better at stopping tumor growth that can be seen on a bone scan or CT scan and the effect of each regimen on lowering Prostate Specific Antigen (PSA values). Participants will be in the study for 6 to 24 months.

Emmanuel Antonarakis
18 years and over
This study is NOT accepting healthy volunteers
SITE00001730
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Inclusion Criteria:

• diagnosis of adenocarcinoma of the prostate
• spread (metastatic) to other organs or bone
• one chemotherapy treatment for hormone sensitive prostate cancer is allowed
• previous treatment required, study staff will review
• able to care for self with little help
Exclusion Criteria:

• prior chemotherapy with docetaxel or cabazitaxel for CRPC
• other severe medical conditions, study staff will review
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Metastatic Prostate Cancer (CRPC), Prostate cancer
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Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies

The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.

Elliot Arsoniadis
18 years and over
This study is also accepting healthy volunteers
STUDY00017257
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Inclusion Criteria:

• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Cancer, Prevention & Wellness
Clinics and Surgery Center (CSC), Anal Cancer
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A feasibility study of topical cannabinoids for treatment of aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) in women with hormone receptor-positive breast cancer (CanAroma)

Aromatase inhibitors (AIs) are commonly used in treating hormone-positive breast cancer. Unfortunately, many patients receiving this treatment experience Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS), with symptoms like joint and bone pain and joint stiffness. The current therapies used to improve AIMSS symptoms have limited effectiveness and can cause their own side effects. In this research study, we are examining the feasibility of topical medical cannabis cream as a treatment option for AIMSS.

Anne Blaes, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00015727
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Inclusion Criteria:

• Stage I-III Breast Cancer.
• Currently taking Aromatase Inhibitor for at least 60 days.
• Aromatase Inhibitor use for no more than 48 months.
• Experiencing aromatase inhibitor-associated musculoskeletal syndrome (AIMSS) symptoms.
• Minnesota resident
Exclusion Criteria:

• Currently using or has used cannabinoid products in the past 4 weeks.
• Active skin lesions on hands/wrists.
• Current or planned acupuncture treatments to hands and wrists.
• Plan to increase doses of other pain medications for improving AIMSS symptoms.
Cancer
aromatase inhibitors, hand, pain, stiffness, wrist
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