No Placebo-Only Group

Pivotal Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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 if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Combination Chemotherapy + Monoclonal Antibody for Acute Myeloid Leukemia

This study is evaluating whether chemotherapy with or without monoclonal antibodies is more effective for treating people with acute myelogenous leukemia.

I will use effective birth control during and for 1 month after the study.

I have a serious infection that isn't getting better with treatment.

I have been diagnosed with acute myelogenous leukemia.

My bilirubin level is above 2.0 mg/dL, not due to Gilbert's disease or leukemia.

My heart's left ventricle isn't working properly.

I haven't had recent serious heart problems.

I can perform most of my daily activities without assistance.

I do not have leukemia in my brain or spinal cord.

I do not have any other cancer that needs treatment.

My blood, liver, kidney, and heart meet the trial's health requirements.

I do not have leukemia in an advanced stage.

I am currently receiving treatment for cancer.

I do not have any serious infections that aren't controlled by medication.

Cytarabine

Daunorubicin

Monoclonal Antibody Therapy

OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system.

II. Determine whether neurologic outcome is improved in these patients when treated with this regimen.

III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients.

IV. Determine the safety of this regimen in these patients.

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System

Oral Acyclovir for Herpes

This study is evaluating whether a drug called acyclovir can be used to treat babies with herpes simplex virus infections of the brain.

I am breastfeeding and have been on acyclovir, valacyclovir, or famciclovir for more than 5 days.

My infant has a herpes infection in the brain, possibly affecting other organs.

I have had a severe brain bleed in the past.

I have tested positive for herpes (HSV-1 or HSV-2) from a skin lesion or through a CSF PCR test.

My child was born to an HIV positive mother.

I do not have infections in my skin, eyes, or mouth.

My brain or spinal cord is affected by my condition.

My cancer has spread to other parts of my body.

Acyclovir

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 purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.

Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

Visilizumab for Graft-versus-Host Disease

This study is evaluating whether an investigational monoclonal antibody can be used to treat patients with glucocorticoid-refractory GVHD.

My kidney, liver, heart functions, and blood counts are within normal ranges.

I have had a bone marrow transplant from a donor.

I have symptoms like skin thickening, stiff joints, mouth sores, or diarrhea.

I have moderate to severe graft-versus-host disease.

My condition worsened or didn't improve after therapy, within 100 days post-transplant.

Visilizumab

This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.

Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

Sitaxsentan for Pulmonary Arterial Hypertension

This study is evaluating whether a medication called sitaxsentan can improve the health of people with pulmonary arterial hypertension.

I have sleep apnea that is not well-managed.

I have a history of certain heart conditions affecting the left side.

I have moderate to severe heart condition symptoms.

I have high blood pressure in the lungs due to a specific heart condition or connective tissue disease.

I have used Flolan or Tracleer in the last 30 days.

Sitaxsentan

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 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 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

Exemestane

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.

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