No Placebo-Only Group

Pivotal Trial

RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum.

PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin damage in patients with xeroderma pigmentosum.

T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum

T4N5 Liposome Lotion for Xeroderma Pigmentosum

This study is evaluating whether a cream can reduce the number of actinic keratoses in people with xeroderma pigmentosum.

I have had all precancerous skin spots removed.

I have been diagnosed with xeroderma pigmentosum.

I have been diagnosed with at least one actinic keratosis.

Placebo Lotion

T4N5 Liposome Lotion

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether giving monoclonal antibody therapy is more effective than a placebo in treating patients with ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery and chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients with residual disease from stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer following surgery and chemotherapy.

Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy

Monoclonal Antibody Therapy for Ovarian Cancer

This study is evaluating whether monoclonal antibody therapy is more effective than a placebo in treating patients with residual disease from stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer following surgery and chemotherapy.

I can take care of myself and perform daily activities.

I've had more than one chemotherapy regimen and my last treatment was less than 4 weeks ago.

I still have visible or palpable cancer after initial surgery.

I have not had radiotherapy in my abdomen area in the last 4 weeks.

My CA 125 levels were high before or at the time of my surgery.

I had surgery less than 4 weeks ago and have had more than one debulking procedure.

My ovarian, tubal, or peritoneal cancer responded completely to initial treatment.

I had immunotherapy or used mouse-derived antibodies less than 6 weeks ago.

My bilirubin levels are not more than 1.5 times the normal upper limit.

My creatinine level is 1.6 mg/dL or lower.

Monoclonal Antibody Therapy

The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.

hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

Immunotherapy for Type 1 Diabetes

This study is evaluating whether a drug called hOKT3gamma1 can prevent rejection of islet transplants.

I am receiving a pancreas cell transplant from a donor.

I have type 1 diabetes with ongoing symptoms despite working closely with my care team.

hOKT3gamma1 (Ala-Ala)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer

Combination Chemotherapy + IM-862 for Ovarian Cancer

This study is evaluating whether a combination of chemotherapy and IM-862 might be more effective than chemotherapy alone in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

I am not currently undergoing gene therapy.

I am not currently receiving IL-2 treatment.

I have not had chemotherapy for my current cancer.

I am not currently taking any drugs that stop the formation of new blood vessels.

I have not had radiation for my current cancer.

I have stage III ovarian or primary peritoneal cancer.

I had surgery to reduce my tumor size within the last 6 weeks.

My surgery removed the cancer well, leaving no large remaining tumors.

All my cancer outside the reproductive tract has been removed.

My liver function tests are within normal ranges.

My kidney function tests are within normal ranges.

I haven't had any other cancer in the last 5 years.

I don't have any serious illnesses that would shorten my life.

I am in good overall health with no major medical or social issues affecting study participation.

I can take care of myself but might not be able to do heavy physical work.

I have had surgery to remove my uterus, ovaries, and fallopian tubes.

I have not received IL-2 treatment recently.

I have not received hormone therapy for my current cancer.

I am not receiving any other chemotherapy treatments.

I haven't had biologic therapy for my current cancer.

Combination Chemotherapy

IM-862

Approved for 10 Other Conditions

All Individual Drugs Already Approved

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

Combination Chemotherapy for Ewing's Sarcoma

This study is evaluating whether a combination of chemotherapy and radiation therapy is more effective than chemotherapy alone in treating Ewing's sarcoma.

My cancer is a type of Ewing's sarcoma or related.

My disease is either operable, was operated on, needs or doesn’t need immediate radiotherapy, has spread to lungs/pleura or beyond, and it’s been less than 45 days since my definitive biopsy.

My kidney function is normal, with a filtration rate of 60 mL/min or more.

My heart functions normally, with good pumping ability.

I don't have any health or social issues that would stop me from joining the study.

Autologous Hematopoietic Stem Cell Transplantation

Busulfan

Conventional Surgery

Dactinomycin

Doxorubicin Hydrochloride

Etoposide

Ifosfamide

Melphalan

Radiation Therapy

Vincristine Sulfate

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Isotretinoin +/- Immunotherapy for Neuroblastoma

This study is evaluating whether a combination of chemotherapy, isotretinoin, dinutuximab, aldesleukin, and sargramostim is more effective than chemotherapy alone in treating patients with neuroblastoma.

My heart's pumping ability is confirmed to be normal by recent tests.

I have high-risk neuroblastoma, or it became high-risk after initial diagnosis.

I completed therapy for my cancer, including intensive treatment and a stem cell transplant.

My seizures are under control with medication and I have no severe brain-related side effects.

My parent or guardian has given written consent for me to participate.

I am eligible for a second stem cell transplant.

My latest bone marrow tests show less than 10% tumor cells before my stem cell transplant or joining this study.

I started my first chemotherapy for high-risk neuroblastoma less than 12 months ago.

I've had recent scans and tests to check my cancer's stage before joining the trial.

I've completed therapy for neuroblastoma, including intensive treatments and possibly surgery.

I am eligible for a tandem transplant and have followed specific treatment protocols within the last 12 months.

My veno-occlusive disease is stable or getting better.

My lung function tests are above 60% of what's expected, or I'm a child without breathing issues.

My neuroblastoma shows a positive response according to specific criteria before stem cell transplant.

My kidney function is within the required range for my age and gender.

I have never received GD2 antibody therapy.

I can do most activities and my doctor thinks I have at least 2 months to live.

I still have cancer after radiotherapy but haven't had a biopsy.

My neuroblastoma shows a positive response to treatment before stem cell transplant.

My kidney function is normal or near normal.

Aldesleukin

Dinutuximab

Isotretinoin

Sargramostim

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.

The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Early Treatment for Retinopathy of Prematurity

This study is evaluating whether early treatment of retinopathy of prematurity (ROP) can improve vision.

My baby was born weighing less than 1251 grams and was either born at or examined by a participating center within 42 days of life.

My infant has a severe eye condition due to premature birth.

Early Treatment

This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Radiation + Chemotherapy for Medulloblastoma

This study is evaluating whether standard-dose radiation therapy works better than reduced-dose radiation therapy in treating young patients with medulloblastoma.

I have not had any radiotherapy treatments before.

My cancer, medulloblastoma, is confirmed and located in the back of my brain.

My condition is considered standard-risk.

My remaining cancer is smaller than 1.5 cm^2 and not widespread, confirmed by a recent MRI.

My cancer has not spread to my brain, spine, or cerebrospinal fluid.

I can perform most of my daily activities without help.

My bilirubin levels are within normal range for my age.

My liver enzymes are within normal limits for my age.

Cisplatin

Craniospinal Irradiation

Cyclophosphamide

Involved-Field Radiation Therapy

Lomustine

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer.

PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

Colonoscopy vs Fecal Occult Blood Test for Colorectal Cancer Screening

This study is evaluating whether a screening test is better than another.

I have had a condition where my lymphocytes grow abnormally.

I am healthy and at average risk for colorectal cancer.

I haven't taken any NSAIDs in the last 7 days.

I am not receiving any cancer treatment except for nonmelanoma skin cancer.

I do not have chronic obstructive pulmonary disease.

I have a family history of multiple colon polyps.

I have not had a heart attack in the last year.

I haven't had cancer in the last 5 years, except for skin cancer.

I have never had inflammatory bowel disease.

I am not receiving chemotherapy, except for treating nonmelanoma skin cancer.

annual screening

fecal occult blood test

screening colonoscopy

standard follow-up care

Approved for 50 Other Conditions

This clinical trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more cancer cells.

Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

Surgery, Radiation & Chemotherapy for Early-Stage Hodgkin's Lymphoma

This study is evaluating whether surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease.

I have been newly diagnosed with LPHD and haven't received any treatment.

My cancer is in the early stage and hasn't grown large.

My cancer is at an early stage and has not formed a large tumor.

I agree not to breastfeed if I receive chemotherapy or radiation.

I am a woman who can have children and have a negative pregnancy test before starting treatment.

I haven't taken systemic corticosteroids in the last 30 days.

My creatinine level is not above 1.5 mg/dL.

I am pregnant or breastfeeding, have stage I cancer with one lymph node involved, and had a complete surgery.

I agree to use effective birth control during my chemotherapy or radiation treatment.

My creatinine level is not above 1.2 mg/dL, and I am between 10 to 12 years old.

My LPHD diagnosis follows specific international standards.

My kidney function is appropriate for my age and gender.

My creatinine level is not above 1.0 mg/dL, and I am between 6 and 9 years old.

My child's creatinine level is not above 0.8 mg/dL.

Prednisone

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

Lenalidomide for Multiple Myeloma

This study is evaluating whether lenalidomide might be an effective treatment for multiple myeloma.

I am fully active or restricted in physically strenuous activity but can do light work.

My lungs work well enough to breathe without symptoms.

My multiple myeloma is active and needs treatment, and I've responded to initial therapy.

I started my first cancer treatment less than a year ago.

I have collected the required number of stem cells for my treatment.

My cancer did not worsen after my first treatment, and I've had no more than two treatment plans.

I am not pregnant or nursing and will follow strict birth control measures if of childbearing age.

I have not had any blood, bone marrow, or organ transplant.

I do not have any serious infections right now.

My heart pumps well, with an ejection fraction of 40% or higher.

I have had less than a year of treatment, including specific medications.

Lenalidomide

This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Chemotherapy +/− Bevacizumab for Stage II Colon Cancer

This study is evaluating whether a combination of chemotherapy and bevacizumab is more effective than chemotherapy alone in treating patients who have undergone surgery for stage II colon cancer.

I have had a condition where my lymphocytes multiply unusually.

I haven't had any cancer except for skin cancer in the last 5 years.

I have a tumor sample available for specific genetic testing.

I have not had a heart attack or unstable angina in the last year.

I have symptoms related to poor blood flow in my limbs.

I do not have more than one tumor at the same time.

My lab tests for Step 2 were done within the last 2 weeks.

I have not had a stroke or mini-stroke in the last year.

I do not have symptoms from peripheral vascular disease.

My cancer has spread to the mesentery but without clear lymph node involvement.

I have had radiation therapy to my pelvic area before.

University Of Minnesota Clinical Trials 2022

Trials at this site

Immunotherapy for Type 1 Diabetes

Early Treatment for Retinopathy of Prematurity

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