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Search Results Within Category "Cancer"

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Suggestions within category "Cancer"

105 Study Matches

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guerin (BCG) in Participants with BCG-naive High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) (SunRISe-3)

The purpose of this study is to compare the effects (both good and bad) of an investigational drug delivery system (TAR-200) in combination with cetrelimab or TAR-200 alone to the effects of study drug comparator intravesical (medicine that is put directly into the bladder instead of being taken like a pill or put into veins) BCG in patients with HR-NMIBC. Cetrelimab is a medicine that may treat certain cancers by working with the immune system (it is also known as immunotherapy). Immunotherapy is the use of medicines to help a person’s own immune system recognize and destroy cancer cells.

Joseph Zabell
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019140
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Inclusion Criteria:

• diagnosis of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS])
• have not received Bacillus Calmette Guerin (BCG)
• cancer must be surgically removed
• 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
Exclusion Criteria:

• more extensive bladder cancer (muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2))
• history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)
• Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
• additional exclusion criteria (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bladder Cancer
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MT-2018-20: COG AALL1631 - International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients (> 1 year and < 21 years) with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, 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. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000271
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Inclusion Criteria:

• >= 1 year (365 days) and =< 21 years at ALL diagnosis
• Diagnosis: Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 WHO definition) with definitive evidence of BCR-ABL1 fusion by karyotype, FISH and/or molecular methodologies. OR
• Diagnosis: ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABLclass fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA.
• see link to clinicaltrials.gov for complete Inclusion Criteria
Exclusion Criteria:

• known history of chronic myelogenous leukemia (CML)
• ALL developing after a previous cancer treated with cytotoxic chemotherapy
• Down syndrome
• patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
Cancer
Acute Lymphoblastic Leukemia, ALL, B Acute Lymphoblastic Leukemia, T Acute Lymphoblastic
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Ten Thousand Families Study

The purpose of this study is to study the evolution of early life risk factors that may lead to cancer and other conditions. This is a prospective cohort study of families who reside in Minnesota.

Jen Poynter
Not specified
This study is also accepting healthy volunteers
STUDY00000877
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Inclusion Criteria:

• 1st Participant: 18+ living in MN
• Other family members: All ages and must live in MN, ND, SD, IA, or WI
• Participants ages 0-17 must have a parent consent to their participation and assist with study activities
Exclusion Criteria:

• Unwilling or unable to provide DNA and blood sample
• Does not have at least 1 living family member in MN IA, ND, SD, or WI
Cancer, Microbiota, Prevention & Wellness
Minnesota, PFAS, environment, exposures, family, genetics, glyphosate, lifestyle, radon, 10KFS
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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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AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00001674
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Inclusion Criteria:

• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
Exclusion Criteria:

• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
Cancer
lung cancer, osteosarcoma, pulmonary metastases, thoracotomy
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The effects of cigarette smoking and alcohol on DNA damage in the oral cavity

The purpose of this study to examine the effects of cigarette smoking and drinking alcohol on the formation of DNA damage in the mouth. The overall goal is to identify DNA damage that may be important to the development of head and neck cancers.

Stephen Hecht, PhD
18 years and over
This study is also accepting healthy volunteers
STUDY00021212
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Inclusion Criteria:

• 21 years of age or older
• Smoke cigarettes daily
• Drink alcohol regularly
Exclusion Criteria:

• Use other tobacco/nicotine products
Prevention & Wellness, Cancer
alcohol, cigarettes, drinking, Smoking, tobacco
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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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COG ARST2032: A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

Emily Greengard
Not specified
This study is NOT accepting healthy volunteers
SITE00001858
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Inclusion Criteria:

• 21 or younger at time of enrollment
• newly diagnosed embryonal rhabdomyosarcoma (ERMS), spindle cell/sclerosing RMS, or FOXO1 fusion negative alveolar rhabdomyosarcoma
• must be enrolled in APEC14B1 (NCT02402244) prior to enrollment and treatment on ARST2032 (this trial)
• contact study team for more detailed criteria
Exclusion Criteria:

• received prior chemotherapy and/or radiation therapy for cancer prior to enrollment
• unable to undergo radiation therapy
• Females who are pregnant
Cancer, Cancer, Children's Health
Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
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AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Peter Gordon
5 years to 60 years old
SITE00001972
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Inclusion Criteria:
Patients must be 5 to 60 years of age at the time of enrollment Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]) with stage I or II disease Patients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained Pediatric patients (age 5-17 years) must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease. Adult patients must have either a CXR or CT chest Patients >= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2 Patients =< 17 years of age must have a Lansky performance score of >= 50 Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): 2 to < 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female) 6 to < 10 years (age): 1 mg/dL (male), 1 mg/dL (female) 10 to < 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female) 13 to < 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female) >= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance >= 50 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard) Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility For adult patients (age 18 years or older) (within 7 days prior to enrollment): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight Total bilirubin =< 2 x upper limit of normal (ULN) (within 7 days prior to enrollment) Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome Aspartate aminotransferase (AST) =< 3 x ULN (within 7 days prior to enrollment) Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome Alanine aminotransferase (ALT) =< 3 x ULN (within 7 days prior to enrollment) Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome Shortening fraction of >= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 7 days prior to enrollment) or ejection fraction of >= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 7 days prior to enrollment) Diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 7 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of > 92% on room air Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
Patients with nodular lymphocyte predominant Hodgkin lymphoma Patients with a history of active interstitial pneumonitis or interstitial lung disease Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to > 10 mg daily prednisone for patients >= 18 years or > 0.5 mg/kg [up to 10 mg/day] for patients < 18 years) or other immunosuppressive medications within 14 days prior to enrollment Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=< 10 mg daily for patients >= 18 years or =< 0.5 mg/kg [up to 10 mg/day] prednisone equivalents) are permitted in the absence of active autoimmune disease Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1 Patients with peripheral neuropathy > grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL Prior solid organ transplant Prior allogeneic stem cell transplantation Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus calmette guerin [BCG], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of < 1% per year when used consistently and correctly) for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Cancer
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A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours

This is an early study of a new drug, called [225Ac]-FPI-1434, to treat solid tumors that have not responded to usual treatment. We are testing different doses of the drug and looking at how well it works for treating the cancer and side effects that occur.

Douglas Yee, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013618
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Inclusion Criteria:

• advanced solid tumor that is refractory to all standard treatment, for which no standard treatment is available, or it is contraindicated, or the patient refuses standard therapy
• restricted in strenuous activity but can walk and is able to do light work e.g., light house work, office work
• contact study staff for additional requirements
Exclusion Criteria:

• inability to perform the required imaging procedures (e.g., inability to lay flat during scan time)
• uncontrolled brain metastasis
• history of organ transplantation, including stem cell transplantation
• other significant medical or mental health diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Advanced 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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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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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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A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma Protocol Number: CA224069 (RELATIVITY-069)

CA224069 is an open-label, Phase 1/2 clinical trial of relatlimab + nivolumab in children, adolescents and young adults with Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) and Non-Hodgkin Lymphoma (NHL). Part A will encompass safety and dose determination of relatlimab + nivolumab. Part B will be composed of an expansion cohort of cHL (Cohort 1) and an exploratory assessment in NHL (Cohort 2).

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00001545
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Inclusion Criteria:

• up to 30 years old
• pathologically confirmed high-risk recurrent/relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL), after non-response to or failure of first-line standard therapy prior to a definitive therapy e.g.high-dose chemotherapy/autologous stem cell transplant (HDCT/ASCT)
• participants with pathologically confirmed R/R NHL after failure or non-response to second line therapy, including but not limited to primary mediastinal B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal gray zone lymphoma (MGZL), anaplastic large cell lymphoma (ALCL), or peripheral T-cell lymphoma (PTCL)
Exclusion Criteria:

• aggressive B-cell lymphomas subtypes including Burkitt lymphoma (BL), lymphoblastic lymphoma, and NK/T-cell lymphoma/leukemia
• prior autologous stem cell transplantation (HDCT/ASCT)
• see link to clinicaltrials.gov for additional exclusion criteria
Cancer
Hodgkin Disease, Lymphoma, Non-Hodgkin
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MT2022-52: Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) with Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

Stem cell transplants (sometimes referred to as a bone marrow transplants) have been done for over 40 years but research continues to further refine the method to reduce side effects without affecting transplant success. The purpose of this study is to improve on transplant outcomes while reducing the potential side effects based on what has been learned from previous transplant studies using a reduced intensity preparative regimen. Information collected during this study (transplant outcomes and side effects) will be compared with the outcomes of the previous reduced intensity conditioning transplant study that enrolled more than 300 patients since 2002.

Mark Juckett
18 years and over
This study is NOT accepting healthy volunteers
STUDY00017906
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Inclusion Criteria:

• up to 75 years of age
• have a matched related donor
• additional criteria for diagnosis, and physical status (study staff will review)
Exclusion Criteria:

• women who are pregnant or breast feeding
• active central nervous system malignancy
• untreated active infection
• additional criteria for exclusion (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Bone Marrow Transplant, Leukemia, Stem Cell Transplant
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ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study (ACTION)

The study will test dordaviprone (also known as ONC201), a new drug that is being developed for treating people with glioma. ONC201 may help to remove tumor cells without affecting normal cells of the body. ONC201 is a first-in-class drug, which means it is a new drug having unique action.

Elizabeth Neil
Not specified
This study is NOT accepting healthy volunteers
STUDY00021033
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Inclusion Criteria:

• body weight at least 10 kg (22 pounds)
• new diagnosis of H3 K27M-mutant diffuse glioma
• started radiotherapy within 12 weeks from the initial diagnosis
• completed radiotherapy within 2 to 6 weeks prior to starting the study treatment
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• primary spinal tumor
• diffuse intrinsic pontine glioma (DIPG)
• evidence of leptomeningeal spread of disease or cerebrospinal fluid dissemination
• received whole-brain radiotherapy or proton therapy
• study staff will review additional criteria
Cancer
Clinics and Surgery Center (CSC), Brain Cancer, Glioma, H3 K27M
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I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)

The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.

Douglas Yee, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00011111
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Inclusion Criteria:

• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
Exclusion Criteria:

• other medical or mental health diagnosis that would limit compliance with study requirements
Cancer
Breast Cancer, Breast Tumors, I-SPY, ISPY, ISPY2

Screening Study to Determine HLA Type, HLA Loss of Heterozygosity Status and Tumor Antigen Expression in Participants with Locally Advanced (Unresectable) or Metastatic Solid Tumors

The purpose of this screening study is to collect samples to conduct the testing of specific human leukocyte antigen (HLA). TScan Therapeutics is developing cellular therapies across multiple solid tumors in which the eligibility criteria require that participants have specific HLA types. The results from this screening study will be used to determine if participants meet the eligibility criteria and could potentially be enrolled in a future TScan treatment study.

Benjamin Manning
18 years and over
This study is NOT accepting healthy volunteers
STUDY00019929
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Inclusion Criteria:

• have one of the following confirmed locally advanced (unresectable) or metastatic solid tumor: Head and neck cancer, cervical cancer, non-small cell lung cancer, melanoma, ovarian cancer, HPV positive anogenital cancer HPV positive anogenital cancers
Exclusion Criteria:

• undergoing anticancer therapy with curative intent
Cancer
Clinics and Surgery Center (CSC), anal, Cervical, genital, Head and Neck, HPV16, Melanoma, Non Small Cell Lung, Ovarian, Solid Tumor
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COG AALL1621 - A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients (≥1 year and < 22 years ) with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000160
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Inclusion Criteria:

• 1 to 21 years old
• must have B Acute Lymphoblastic Leukemia (B-ALL), or previously diagnosed B lymphoblastic lymphoma (B-LL)
• Patients with one of the following: Second or greater relapse; Primary refractory disease with at least 2 prior induction attempts; First relapse refractory to at least one prior re-induction attempt; OR Any relapse after HSCT (Cohort 1 ONLY)
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:

• currently receiving another investigational drug
• currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)
Cancer
B-LL, Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma. B-ALL
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MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study

The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).

Punita Grover
Not specified
This study is NOT accepting healthy volunteers
STUDY00014365
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Inclusion Criteria:

• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:

• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
• pregnancy
• women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
Cancer
Clinics and Surgery Center (CSC), Acute-graft-versus-host Disease, aGVHD, HCT, Hematopoietic Cell Transplant
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MT2023-10: A Phase 1 Study of FT522 in Combination with Rituximab in Participants with Relapsed/Refractory B-Cell Lymphoma

We are studying FT522 - a new product that is made by modifying cells in a laboratory - both with and without additional drugs, to see if it can help treat people with B-cell lymphoma. This study is for people who have had at least one treatment for their lymphoma, but the cancer either returned or did not respond to the treatment. We are testing this product to see what side effects it might have, as well as to see whether it is effective at treating B-cell lymphoma.

Veronika Bachanova, MD
18 years and over
This study is NOT accepting healthy volunteers
SITE00001976
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Inclusion Criteria:

• diagnosis of B-cell lymphoma (BCL)
• at least 1 prior systemic regimen of treatment
• men and women participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
Exclusion Criteria:

• women who are pregnant or breastfeeding
• capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
• body weight less than 50 kg (110 lb.)
• additional medical diagnosis (study staff will review)
Cancer
Clinics and Surgery Center (CSC), Lymphoma, Relapsed/Refractory B-Cell Lymphoma
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COG AALL2121: A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia

This phase II trial tests the safety and best dose of revumenib when given together with chemotherapy, and how well the treatment regimen works for infants and young children with leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R). Revumenib is an oral medicine that directly targets the changes that occur in a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia cells in test tubes and animals. Drugs used in chemotherapy, such as vincristine, prednisone, asparaginase, fludarabine and cytarabine 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. This trial is being done to find out if the combination of revumenib and chemotherapy may help to treat the cancer cells better than either treatment alone.

Peter Gordon
Up to 18 years old
This study is NOT accepting healthy volunteers
STUDY00021176
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Inclusion Criteria:

• Age: Patients must be 1 month to less than 6 years old at the time of study enrollment and must have had initial diagnosis of leukemia less than 2 years old.
• Diagnosis: Patients must have KMT2A-rearranged acute lymphoblastic leukemia (ALL), acute leukemia of ambiguous lineage (ALAL), or mixed phenotype acute leukemia (MPAL), which is determined to be refractory or in first marrow relapse.
• Disease status: First relapse, refractory or failure to achieve remission
Exclusion Criteria:

• Patients with isolated extramedullary leukemia.
• Patients diagnosed with Down syndrome.
Cancer
ALAL, ALL, leukemia, MPAL, relapse
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COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Peter Gordon
Not specified
This study is NOT accepting healthy volunteers
SITE00000723
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Inclusion Criteria:

• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ?25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
• lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• see link to clinicaltrials.gov for complete exclusion criteria
Cancer
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Leukemia, Testicular Leukemia
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HM2023-07: Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy (MonumenTAL-3)

Talquetamab is an experimental medication being studied to see if it may be beneficial in the treatment of multiple myeloma.

Daniel O'Leary
18 years and over
This study is NOT accepting healthy volunteers
STUDY00018679
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Inclusion Criteria:

• diagnosed with multiple myeloma that has not responded to treatment or has reoccurred after at least one treatment
• able to care for self with some assistance
Exclusion Criteria:

• active cancer in central nervous system or clinical symptoms
• maximum amount of steriods taken in the past two weeks (study staff will review)
• disease hasn't responded to this type of drug (anti-CD38 monoclonal antibody)
Cancer
Multiple Myeloma
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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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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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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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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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A Parallel-group, Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)

This study will investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations. This study is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study with two cohorts: Cohort A followed by Cohort B. The purpose of Cohort A is to provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas, and provide guidance for the correct dose, population, sample size, and endpoint for the confirmatory part of the study (Cohort B). Additional goals for Cohort A are to assess effects of food on drug absorption. The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas.

Christopher Moertel, MD
Not specified
This study is NOT accepting healthy volunteers
SITE00001508
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Inclusion Criteria:

• at least 12 years old weighing at least 40 kg (88 pounds)
• progressive meningioma that is amenable to volumetric analysis
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:

• progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation - therapy within the next 3 months
• received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening
• see link to clinicaltrials.com for all exclusion criteria
Cancer
Neurofibromatosis Type 2
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