Pivotal Trial

No Placebo-Only Group

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

High-Dose Interferon Alfa for Melanoma

This study is evaluating whether interferon alfa can improve survival for people with melanoma.

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.

My cancer is stage III with a tumor thicker than 4mm or has spread to one lymph node.

Interferon alfa-2b

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.

PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

Chemotherapy for Breast Cancer

This study is evaluating whether a combination of drugs is more effective than a single drug in treating breast cancer.

I have had surgery to remove breast cancer and affected lymph nodes.

I haven't had cancer in the past 5 years, except for certain skin cancers or early-stage cervical or breast cancer.

My cancer is at an early or mid-stage and can be operated on.

I know my cancer's estrogen and progesterone receptor status.

My tumor is smaller than 1 cm and doesn't meet certain criteria.

I have breast cancer in both breasts, diagnosed within a month of each other, and the more advanced tumor meets the study criteria.

My breast cancer is confirmed and not spread beyond stage III.

My tumor is larger than 2 cm or larger than 1 cm with specific features.

My cancer has not spread to my lymph nodes and my tumor is at least 1 cm with high-risk features or larger than 2 cm.

My cancer has not spread to nearby tissues.

My breast cancer has not spread to underarm or breast nodes.

My breast cancer has spread to my lymph nodes.

Cyclophosphamide

Doxorubicin Hydrochloride

Paclitaxel

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.

My kidney function is normal or near normal.

Cisplatin

Craniospinal Irradiation

Involved-Field Radiation Therapy

Lomustine

Radiation Therapy

Vincristine Sulfate

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.

Conventional Surgery

Prednisone

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.

Bevacizumab

Docetaxel

Gemcitabine Hydrochloride

Pemetrexed Disodium

Questionnaire Administration

Vinorelbine Tartrate

This phase III trial is studying vincristine, dactinomycin, and doxorubicin with or without radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor. Drugs used in chemotherapy, such as vincristine, dactinomycin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.Giving these treatments after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor

Chemotherapy +/− Radiation for Kidney Cancer

This study is evaluating whether chemotherapy and radiation therapy are more effective than observation only for treating patients with Wilms' tumor.

My condition fits into one of the required disease categories.

I have not had chemotherapy or radiotherapy for my tumor.

My condition is considered very low-risk.

I am transferring from AREN03B2 with specific genetic changes.

I have Denys-Drash syndrome or similar urinary tract issues.

My cancer is in the early stage (Stage I).

My heart's pumping ability is within a healthy range.

My lymph nodes do not have cancer, confirmed by a biopsy.

My cancer is in an early to mid-stage (I-III).

I do not have Wilms tumors in both kidneys at the same time.

My genetic test shows no loss on chromosomes 1p and 16q.

My condition is in the early stage (Stage I).

My child can do most activities but may need assistance.

The size of the tumor is greater than 500 grams.

My condition does not need radiation treatment.

I have been diagnosed with Simpson-Golabi-Behmel syndrome.

My early-stage cancer shows specific genetic changes.

Your bilirubin (direct) level should not be more than 1.5 times the upper limit of normal.

You don't have any cancer spread to your lungs as shown on a chest CT scan.

I do not have a high-risk genetic condition for kidney cancer.

My condition is confirmed as Wilms' tumor.

Your liver enzymes (AST or ALT) are not more than 2.5 times the upper limit of normal.

I have a unilateral Wilms tumor without risk factors for developing it on both sides.

My child under 1 year has a specific kidney condition.

You need to have a test that shows you are not pregnant.

I am over 16 and can do most activities without help.

3-dimensional conformal radiation therapy

3-Dimensional Conformal Radiation Therapy

Dactinomycin

Therapeutic Conventional Surgery

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor

Chemotherapy + Radiation for Kidney Cancer (Wilms' Tumor)

This study is evaluating how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor.

I can perform most of my daily activities without assistance.

Your liver enzymes (AST or ALT) are not more than 2.5 times the normal level.

I haven't had chemotherapy or radiotherapy, except as part of COG-AREN0532 or for urgent medical reasons.

I have been recently diagnosed with Wilms' tumor at a specific stage.

Your bilirubin levels are within a certain range.

I will start treatment within 2 weeks after my surgery or biopsy, unless my doctor advises against it.

Your heart's pumping function is normal, as shown by specific heart tests.

3-dimensional Conformal Radiation Therapy

Etoposide

Liposomal Vincristine Sulfate

RATIONALE: Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.

Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer

Surgical Procedures for Early-Stage Lung Cancer

This study is evaluating whether wedge resection or segmentectomy is better than lobectomy for treating stage IA non-small cell lung cancer.

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

My lung scans show ground glass opacities or I have N1 or N2 lung cancer.

Your doctor hasn't confirmed that there is no cancer spread using a quick frozen tissue test.

My right-sided tumor's nodes 4, 7, and 10 were not confirmed negative.

I can take care of myself and am up and about more than half of the day.

I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.

My left-sided tumor's lymph nodes at levels 5, 6, 7, and 10 were not confirmed negative.

My lung nodule is 2 cm or smaller, located on the outer part of my lung, and presumed to be cancer.

Lymph nodes that were confirmed to have cancer during a quick frozen section test.

My cancer has not spread beyond its original location.

You have not had a biopsy to confirm that you have non-small cell lung cancer.

Lobectomy

Segmentectomy

Wedge Resection

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation + Chemotherapy for Small Cell Lung Cancer

This study is evaluating whether different radiation therapy regimens work better than others when given together with chemotherapy.

My cancer is confined to one side of my chest and has spread only to nearby lymph nodes.

I have had only one round of chemotherapy that included carboplatin or cisplatin and etoposide.

I have not had surgery to completely remove my cancer.

My lung cancer diagnosis was confirmed through lab tests.

I have a tumor that can be measured by scans.

I do not have fluid in my lungs or, if I do, it has been tested and is not cancerous.

I haven't had chemo or radiation for small cell lung cancer, except as noted before.

My kidney function, measured by creatinine levels or clearance, is within the required range.

My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.

You have a certain type of white blood cells called granulocytes, and you need to have at least 1,500 of them in a tiny drop of blood.

Your AST (SGOT) level is not more than 2 times the upper limit of normal.

Your blood platelet count is at least 100,000 per microliter.

I have not had radiation therapy to my chest area.

I do not have cancer cells in my chest or heart fluid.

I can care for myself and am up and about more than 50% of my waking hours.

Your total bilirubin level is not more than 1.5 times the upper limit of normal.

Carboplatin

High Radiation Dose Therapy

Standard Radiation Dose Therapy

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

Lenalidomide + Dexamethasone +/- Bortezomib for Multiple Myeloma

This study is evaluating whether lenalidomide, dexamethasone, and bortezomib is more effective than dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma.

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