No Placebo-Only Group

Pivotal Trial

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.

Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

Interferon Alfa With/Without Vaccine for Skin Cancer

This study is evaluating whether interferon alfa plus a vaccine is more effective than interferon alfa alone in treating patients with metastatic melanoma.

It has been over a year since I received interferon alfa or a melanoma vaccine.

I have had surgery for cancer that spread.

I have never been diagnosed with eye melanoma.

I haven't taken corticosteroids in the last week.

I am not taking any drugs that weaken my immune system.

My kidneys are working well enough (creatinine clearance is 40 mL/min or more).

My melanoma has spread to other parts of my body.

My heart can pump blood effectively without failure.

I have no other cancers except for non-melanoma skin cancer.

I have not had a heart attack in the last 6 months.

I do not have any heart rhythm problems that cause symptoms.

I am not currently taking cytokines or levamisole.

My thyroid condition is controlled with medication.

It has been over 4 months since my last adjuvant therapy.

I can't be made cancer-free by surgery or I have chosen not to undergo surgery.

I am not currently receiving chemotherapy.

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

I have had radiation therapy for cancer that has spread.

Interferon Alfa

Melanoma Vaccine

The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.

The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment

Antiretroviral Therapy for HIV

This study is evaluating whether it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.

My HIV treatment initially worked, lowering my viral load below 400 in two tests.

My HIV treatment failed twice with viral loads between 400 and 20,000.

I have not used at least one of the specific HIV medications before.

I have been on HIV treatment including indinavir or nelfinavir for at least 16 weeks.

Indinavir

NRTIs

Ritonavir

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

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Hormone Therapy for Breast Cancer

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

I don't have any chronic diseases that would interfere with long-term treatment.

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

My breast cancer cannot be removed by surgery and has spread to nearby areas.

I have not had chemotherapy before or after surgery.

I haven't had any cancer except certain skin cancers or non-spreading breast cancer in the last 5 years.

My estrogen levels are considered premenopausal after surgery.

I have never had a blood clot or if I did, my doctor says it's okay.

My breast cancer diagnosis was confirmed through tissue examination.

My cancer has not spread to distant parts of my body.

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

I do not have liver disease that would interfere with long-term monitoring.

I do not have kidney disease that would interfere with long-term monitoring.

I am not taking any estrogen, progesterone, or androgen treatments.

I am not taking any other aromatase inhibitors.

I don't have any lung diseases that would interfere with long-term monitoring.

I am fertile and not using birth control methods that don't involve hormones.

I haven't had hormone therapy for breast cancer since diagnosis.

I have never had radiation therapy for ovarian cancer.

I am not currently taking bisphosphonates, or I meet the specific criteria for their use.

I haven't used tamoxifen, SERMs, or hormone therapy for over a year before my breast cancer diagnosis.

I am not currently on any oral or patch-based hormone treatments.

I have not had both of my ovaries removed.

I do not have any detectable cancer in the lymph nodes under my arm.

I am a woman who has not gone through menopause.

I have had surgery to remove lymph nodes under my arm or a biopsy that was negative.

I am not using any hormonal contraceptives.

My cancer is only in my breast and nearby lymph nodes.

My cancer was entirely removed by surgery.

I don't have heart disease that would interfere with long-term monitoring.

I have had surgery or radiation on the lymph nodes under my arm due to cancer.

My cancer is positive for estrogen or progesterone.

I have had a condition where my lymphocytes grow abnormally.

I have never had invasive breast cancer before.

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

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 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 have never had a stroke or a mini-stroke.

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