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

All Individual Drugs Already Approved

Approved for 30 Other Conditions

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

Chemotherapy + Monoclonal Antibody Therapy for Non-Hodgkin's Lymphoma

This study is evaluating whether a combination of 2 monoclonal antibodies plus chemotherapy is more effective than a combination of 2 monoclonal antibodies plus chemotherapy in treating patients with newly diagnosed non-Hodgkin's lymphoma.

I have never received monoclonal antibody treatment for cancer.

My lymphoma has not spread to my brain or spinal cord.

I have been diagnosed with congestive heart failure.

I have been diagnosed with cardiomyopathy.

I haven't had any cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.

I have not had radiation therapy for lymphoma.

I have not had chemotherapy for lymphoma before.

My condition is graded between I and III.

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

I have a type of lymphoma that has not been treated and is in an advanced stage.

Cyclophosphamide

Doxorubicin

Rituximab

Tositumomab

Vincristine

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

This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Vaccine Therapy for Patients With Stage III Melanoma

Vaccine Therapy for Stage III Melanoma

This study is evaluating whether a vaccine can prevent or slow the recurrence of melanoma.

All visible signs of my disease have been surgically removed.

I am not on medications or therapies that weaken my immune system.

CancerVax™ Vaccine

This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Vaccine Therapy for Patients With Stage IV Melanoma

Cancer Vaccine for Melanoma

All visible signs of my disease were removed with surgery.

I am not on any treatments that weaken my immune system.

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 IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

Imatinib or Dasatinib for Chronic Myeloid Leukemia

This study is evaluating whether a drug called imatinib mesylate or dasatinib can stop the growth of cancer cells in patients with chronic myelogenous leukemia.

I haven't had major surgery in the last 28 days and have recovered from past surgeries.

My CML is in the chronic phase, confirmed by recent tests.

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

My heart is healthy and I've had an ECG test in the last 42 days without major issues.

I was diagnosed with CML within the last 6 months and tested positive for the Philadelphia chromosome.

I have CML and have only been treated with hydroxyurea or anagrelide.

I haven't had chemotherapy for stem cell mobilization.

I do not have a history of serious bleeding disorders not related to my cancer.

I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.

Dasatinib

Imatinib Mesylate

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.

Doxorubicin Hydrochloride

Paclitaxel

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.

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 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

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.

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