No Placebo-Only Group

Pivotal Trial

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer

This study is evaluating whether ovarian function suppression with either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

My cancer has spread to distant parts of my body.

I have had cancer before, but it fits the exceptions.

My breast cancer was confirmed by a biopsy and is hormone receptor positive.

I became postmenopausal after surgery or chemotherapy.

I have noticeable cancer remaining in my underarm area.

I have had breast cancer before, either in the same or the other breast.

I have had surgery to remove both ovaries or radiation treatment on my ovaries.

I am not pregnant or breastfeeding and do not plan to become pregnant in the next 5 years.

I plan to use hormonal therapy in addition to the study treatment for the next five years.

I have been on hormone therapy for my breast cancer for over 8 months.

I was on tamoxifen or similar hormone therapy within a year before my breast cancer diagnosis.

I have received hormone therapy for breast cancer before being considered for this trial.

My estrogen levels are in the premenopausal range.

I haven't had chemotherapy and it's been less than 12 weeks since my surgery.

I finished my chemotherapy less than 8 months ago.

My cancer is only in my breast and nearby lymph nodes, with no spread elsewhere.

My breast cancer cannot be removed with surgery.

I have had surgery to remove lymph nodes or a biopsy showing no cancer in them.

I had surgery for breast cancer and no remaining signs of cancer in the area.

Exemestane

Oophorectomy

Tamoxifen

Triptorelin

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

Radiation Therapy

Vincristine Sulfate

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.

I haven't had significant bleeding unrelated to my colon cancer in the last 6 months.

I have a serious or non-healing wound, skin ulcer, or bone fracture.

I am currently experiencing significant nerve pain or tingling.

I have not had any major surgeries or procedures recently.

My tumor is located at least 12 cm from the anal opening, as confirmed by a doctor.

My colon cancer is confirmed to be Stage II adenocarcinoma.

I have hereditary non-polyposis colorectal cancer.

I have never had inflammatory bowel disease.

I have never had cancer spread to distant parts of my abdomen.

My surgery removed all visible cancer without leaving any behind.

I haven't started any treatment for my cancer.

I have not had a complete blockage or tear in my intestines.

I do not have another type of cancer besides the one being treated.

I can take care of myself and am up and about more than half of my waking hours.

I will start treatment between 28 and 60 days after my surgery.

I do not have any health conditions that would prevent me from taking the study drugs.

I have a history of high blood pressure that doesn't meet certain criteria.

Bevacizumab

Fluorouracil

Laboratory Biomarker Analysis

Leucovorin Calcium

Oxaliplatin

This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy 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. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Hormone Therapy + Chemotherapy for Breast Cancer

This study is evaluating whether hormone therapy alone or hormone therapy together with chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.

I am receiving treatment for chronic obstructive pulmonary disease.

I am a woman who can have children and am not using birth control.

I had an Oncotype DX test, but my recurrence score wasn't between 11-25.

My cancer is positive for estrogen and/or progesterone receptors.

I have heart issues that prevent me from using certain cancer drugs.

I have had surgery that meets the trial's requirements.

I haven't had chemotherapy or radiation for my cancer.

My tumor is between 5 mm and 5 cm, possibly with aggressive features.

My doctor and I agree to start standard chemotherapy and hormonal therapy after surgery.

I have a breast cancer tissue sample ready for testing.

I have been cancer-free from any previous cancers for at least 5 years.

Anastrozole

Combination Chemotherapy

Letrozole

Tamoxifen Citrate

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer

This study is evaluating whether chemotherapy and bevacizumab are more effective than chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.

Your SGPT (ALT) level in the blood is less than 5 times the upper limit of normal.

I had surgery to remove my lung cancer, which was not a minor procedure, and had specific lymph nodes checked.

Your total bilirubin level must be less than or equal to 1.5 mg/dL.

I haven't had hormone or radiation cancer treatments in the last 5 years.

Your prothrombin time/international normalized ratio (INR) should be 1.5 or less.

My blood clotting time is within the normal range, or if I'm on blood thinners, it's not more than 1.5 times the upper limit.

I am not currently coughing up a significant amount of bright red blood.

I have had heart issues but have been symptom-free for over a year.

You must have a certain amount of a type of white blood cell called neutrophils in your blood.

Women who could become pregnant must take a blood or urine test to make sure they are not pregnant before joining the study.

I haven't had any cancer in the last 5 years, except for cervical in-situ carcinoma or non-melanoma skin cancer that was fully removed.

My blood pressure is under control and below 150/90.

I am on a stable blood thinner regimen or using it for DVT prevention.

I am taking aspirin or NSAIDs daily, but not dipyridamole, ticlopine, clopidogrel, or cilostazol.

I am eligible for pemetrexed/cisplatin therapy.

My lung cancer is not of the squamous cell type.

My kidney function is good, as shown by recent tests.

My blood clotting time is within safe limits while on blood thinners.

Your SGOT (AST) levels are not more than 5 times the upper limit of normal.

I had lung surgery between 6 to 12 weeks ago and have recovered well.

Your kidney function, as measured by a blood test for creatinine, is within a certain range.

I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last month.

I am not expecting to undergo any major surgeries during the study.

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

I have never had a stroke or a mini-stroke.

My urine protein levels are low enough for me to join.

I have never had chemotherapy, except possibly low-dose methotrexate for a non-cancer condition.

I haven't had major surgery, serious injuries, or biopsies recently.

I don't have any serious infections, heart issues, or other conditions that would stop me from following the study's requirements.

You are allergic to Chinese hamster ovary cell products or other similar medicines made from living cells.

Your platelet count must be at least 100,000 per cubic millimeter.

Docetaxel

Gemcitabine Hydrochloride

Pemetrexed Disodium

Questionnaire Administration

Vinorelbine Tartrate

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET

Chemotherapy + Radiation for Medulloblastoma

This study is evaluating whether a combination of chemotherapy and radiation therapy is more effective than either treatment alone in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma.

I should be careful with certain kidney-damaging medications.

My cancer has not spread to distant organs (not M4).

I have been newly diagnosed with medulloblastoma and have not received any treatment.

I have a specific type of brain tumor called diffusely anaplastic medulloblastoma.

I am not taking strong drugs that affect liver enzymes.

My seizure medication will be monitored while I receive cisplatin.

I have not had chemotherapy or radiation therapy before.

I am not taking corticosteroids with my chemotherapy.

I have had a brain MRI with contrast before surgery.

My kidney function, measured by creatinine levels, is appropriate for my age and gender.

I have had a head MRI with contrast after surgery.

I have had an MRI of my spine with a special dye.

Carboplatin

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Combination Chemotherapy for T-Cell Leukemia/Lymphoma

This study is evaluating whether a combination of drugs is more effective than a single drug in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

My T-NHL does not include specific types like B-precursor lymphoblastic lymphoma or involve the brain/testicles.

I have not had chemotherapy, except for steroids or IT cytarabine.

My leukemia is classified as T-ALL based on specific cell markers.

I have been newly diagnosed with T-ALL or T-NHL at stage II-IV.

I've had IT chemotherapy with cytarabine for convenience before joining.

I have T-NHL or T-ALL and may need steroids before starting treatment, affecting my risk classification.

UT Southwestern Clinical Trials 2022

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