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

Drug Has Already Been Approved

The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).

Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

TRIZIVIR + Efavirenz for HIV

This study is evaluating whether a combination of two drugs can reduce the amount of HIV in the blood.

I haven't had radiation, chemotherapy, or immune-affecting drugs in the last 4 weeks.

I have not had an HIV vaccine in the last 3 months nor plan to during the study.

I am committed to completing the study and taking the drugs as required.

If I am under 18, my parent or guardian has agreed to the treatment.

I have a stomach or intestine problem that affects how I absorb medicine.

I am not allergic to the study drugs or their ingredients.

I have been on anti-HIV medication for at least 2 weeks.

I have had hepatitis in the last 6 months.

I have taken medication for HIV that is not a nucleoside.

I am not taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.

Abacavir/Lamivudine/Zidovudine

Efavirenz

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.

The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Early Treatment for Retinopathy of Prematurity

This study is evaluating whether early treatment of retinopathy of prematurity (ROP) can improve vision.

My baby was born weighing less than 1251 grams and was either born at or examined by a participating center within 42 days of life.

My infant has a severe eye condition due to premature birth.

Early Treatment

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver.

PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver.

Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

Interleukin-2 +/- Histamine Dihydrochloride for Skin Cancer

This study is evaluating whether interleukin-2 with or without histamine dihydrochloride is more effective in treating stage IV melanoma that is metastatic to the liver.

My liver function tests are within acceptable limits and I don't have hepatitis B or C.

My creatinine is ≤ 1.7 mg/dL and calcium is ≤ 11.5 mg/dL.

I have had a condition where my lymphocytes grow abnormally.

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

I haven't needed asthma treatment in 5 years and my oxygen levels are good.

I haven't had high-dose IL-2, combo immunotherapy with chemo, or low-dose IL-2 for melanoma in the last year.

I am not on long-term steroids but can use asthma inhalers, creams, or joint injections.

I haven't taken any cancer treatments, investigational drugs, or certain medications recently.

My melanoma is confirmed to be at stage IV.

I have at least one cancer spot that can be measured and was not previously treated with radiation.

My tumor is visible and measurable by scans or physical exam.

I am fully active or able to carry out light work.

I have no signs of cancer spreading to my brain.

My heart is healthy with no recent heart attacks or severe heart disease.

Histamine Dihydrochloride

Interleukin-2

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.

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

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.

Cisplatin

Docetaxel

Gemcitabine Hydrochloride

Pemetrexed Disodium

Questionnaire Administration

Vinorelbine Tartrate

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, 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. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

Chemotherapy +/− Bevacizumab for Breast Cancer

This study is evaluating whether chemotherapy with or without bevacizumab is more effective in treating patients with cancer that has spread to the lymph nodes or cancer that has not spread to the lymph nodes but is at high risk for returning.

My breast cancer is not HER2 positive as determined by specific tests.

I have cancer in both breasts, but the more advanced one qualifies for the trial.

I have had a heart attack in the last 12 months.

My breast cancer is at high risk of spreading.

My breast cancer has spread to at least one of my underarm lymph nodes.

My breast cancer is ER- and larger than 1 cm, or it's ER+ and meets specific size and score criteria.

I had targeted breast radiation before chemotherapy and it's been 4 weeks since.

I need radiation after mastectomy due to a large tumor or many affected lymph nodes.

I haven't had chemotherapy or hormone therapy for my breast cancer, nor used certain cancer drugs before.

My breast surgery removed all visible cancer; LCIS at the margins is okay.

I am fully active or can carry out light work.

It's been 1 to 3 months since my last breast cancer surgery.

I have completed surgery for breast cancer, including removal of the breast or part of it and checking the lymph nodes.

I do not have serious heart or brain blood vessel problems.

I do not have any non-healing wounds, fractures, or recent serious abdominal issues.

I am not allergic to paclitaxel or certain drug ingredients.

I will receive focused breast radiation after chemotherapy.

I have had a stroke, TIA, or bleeding in my brain.

I have heart failure that affects my daily activities.

University Of Louisville Clinical Trials 2022

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