No Placebo-Only Group

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

Pivotal Trial

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 primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer

Immunotherapy with DCVax-L for Brain Cancer

This study is evaluating whether a vaccine can improve survival for people with brain cancer.

I stopped taking steroids at least 10 days before my leukapheresis.

My initial treatment was surgery to remove as much of the tumor as possible, followed by radiation and Temodar chemotherapy.

I agree not to receive certain cancer treatments except for temozolomide as per the Stupp Protocol while on DCVax-L.

My tumor sample from surgery is enough for the protein test.

I have enough DCVax-L available for treatment after it was made.

I have been diagnosed with Grade IV brain cancer in one side of my brain.

My bone marrow, liver, and kidneys are working well.

I am between 18 and 70 years old and can legally consent.

My cancer did not worsen after finishing radiation therapy.

DCVax®-L

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

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

All visible signs of my disease were removed with surgery.

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

CancerVax™ Vaccine

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 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

The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease

3APS for Alzheimer's Disease

This study is evaluating whether a drug called 3APS is safe and effective for people with Alzheimer's disease.

I have been diagnosed with Alzheimer's disease.

I am over 50, and if female, cannot have children.

I live at home or in assisted living with a caregiver who can help me.

I do not have any uncontrolled or significant medical conditions.

I have been on a stable dose of Alzheimer's medication for at least 4 months.

I can speak and write in English, French, or Spanish.

3APS

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

Doxorubicin Hydrochloride

Prednisone

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

RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer.

PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass.

Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass

Proteomic Profiling for Diagnosing Ovarian Cancer

This study is evaluating whether a blood test can help doctors tell whether a patient has ovarian cancer.

I am undiagnosed and will have surgery to find out more within 3 weeks.

I have an abnormal growth in my pelvic area found by a doctor or through imaging.

Proteomic Profiling

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas. Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug. Giving vorinostat together with temozolomide may kill more tumor cells.

Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas

Vorinostat + Temozolomide for Brain Cancer

This study is evaluating the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas.

I have a history of cancer or blood cell disorders.

It has been at least 3 weeks since my last radiation therapy.

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

My condition worsened despite taking temozolomide.

I do not have any active infections or serious illnesses.

I have a condition that affects how drugs are broken down in my body.

I am HIV positive and on antiretroviral therapy.

My hemoglobin level is at least 10 g/dL, transfusions included.

Wake Forest Clinical Trials 2022

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