No Placebo-Only Group

Pivotal Trial

To assess the beneficial and adverse effects of corticosteroid treatment for optic neuritis.

To determine the natural history of vision in patients who suffer optic neuritis.

To identify risk factors for the development of multiple sclerosis in patients with optic neuritis.

Optic Neuritis Treatment Trial (ONTT)

Corticosteroids for Optic Neuritis

This study is evaluating whether corticosteroid treatment for optic neuritis is beneficial or harmful.

I have been treated with steroids for optic neuritis or MS.

I have a condition other than MS that could cause my optic neuritis.

I have had sudden vision problems in one eye for no more than 8 days.

I have never had optic neuritis in the affected eye.

I have an eye condition affecting my pupil's reaction and field of vision.

Corticosteroid

Longitudinal Optic Neuritis Study (LONS)

This study is evaluating whether corticosteroid treatment for optic neuritis is safe and effective.

I have been treated with corticosteroids for optic neuritis or MS.

I have a vision and pupil reaction issue in one eye.

To evaluate the safety of single and multiple doses (28 daily doses) of 9-[2-(R)-[[bis[[(isopropoxycarbonyl)- oxy]methoxy]phosphinoyl]methoxy]propyl]adenine fumarate (PMPA) prodrug administered orally to HIV-infected patients. To determine the pharmacokinetics of single and multiple doses of PMPA prodrug when administered orally to HIV-infected patients. To evaluate the anti-HIV activity of PMPA prodrug, as demonstrated by increases in CD4 cell counts and decreases in HIV RNA, when administered orally as a single dose and daily for 4 weeks to HIV-infected patients with CD4 cell counts of 200 or more cells/mm3.

The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients

PMPA Prodrug for HIV

This study is evaluating whether a drug called PMPA can help people with HIV live longer.

I haven't taken any strong medications or treatments that could harm my kidneys in the last 2 weeks.

I am currently on antiretroviral therapy for HIV.

I have recovered from a serious infection and it's been 2 weeks since I stopped taking IV antibiotics.

I have been on Adefovir dipivoxil for over two weeks.

I do not have serious heart problems like chest pain, heart failure, or irregular heartbeat.

I have a cancer type other than basal cell carcinoma or cutaneous Kaposi's sarcoma.

I haven't taken any HIV medication in the last 2 weeks.

PMPA Prodrug

The purpose of this study is to see if it is safe and effective to give CPI-1189 to patients with AIDS dementia.

Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to loss of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

Safety and Effectiveness of Giving CPI-1189 to HIV-Infected Patients With AIDS Dementia

CPI-1189 for AIDS Dementia

This study is evaluating whether a drug called CPI-1189 might be able to prevent or slow down the progression of AIDS dementia.

I do not have serious conditions like mental disorders or AIDS-related infections.

I experience symptoms like forgetfulness and loss of muscle control.

I have been on a consistent HIV medication regimen for the last 6 weeks.

CPI-1189

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and epinephrine administered directly into the tumor in treating patients who have primary liver cancer that cannot be removed during surgery.

Chemotherapy in Treating Patients With Liver Cancer

Chemotherapy for Liver Cancer

This study is evaluating whether a drug and a drug combination can kill more tumor cells than a drug alone.

I do not have heart disease or severe heart symptoms.

I have not had biologic therapy for liver cancer.

My kidney function, measured by creatinine levels or clearance, is within the required range.

I have not had chemotherapy for liver cancer.

My cancer has not spread to major blood vessels.

I have not had hormone therapy for liver cancer.

I have not had radiotherapy for liver cancer.

I have up to 3 tumors, none larger than 7 cm, and their total volume is under 200 cm3.

I can care for myself but may not be able to do active work.

My liver function tests are within acceptable ranges and I have mild to moderate liver impairment.

My liver cancer cannot be removed with surgery.

Cisplatin

Epinephrine

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or refractory head and neck cancer.

Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer

Paclitaxel for Recurrent or Refractory Head and Neck Cancer

This study is evaluating whether paclitaxel is effective in treating head and neck cancer.

My head or neck cancer has come back or is not responding to treatment.

It's been over 3 weeks since my last immunotherapy and I'm not currently on it.

My heart is generally healthy with no recent major issues.

I haven't had certain strong cancer drugs for at least 5 weeks, and other chemotherapy for 3 weeks.

I stopped hormonal therapy 3 weeks ago, but I may be taking Megace.

I haven't had radiotherapy in the last 3 weeks and none of my treatments targeted more than 30% of my bone marrow.

My kidney function is within the required range and my calcium levels are normal.

My cancer can be measured or seen on tests.

I have had chemotherapy before for my cancer that came back or spread.

I do not have severe numbness or pain in my hands or feet.

I am able to get out of my bed or chair and move around.

My liver function tests are within normal limits.

It has been over 3 weeks since I had major surgery.

I haven't had any injected antibiotics in the last week.

Paclitaxel

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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

Chemotherapy + Vaccine Therapy for Non-Hodgkin's Lymphoma

This study is evaluating whether a combination of chemotherapy and a vaccine is more effective than chemotherapy alone.

I have not taken corticosteroids for lymphoma.

I can take care of myself and perform daily activities.

I haven't taken corticosteroids or immunosuppressants for other conditions in the last year.

I have not received antibody therapy for my lymphoma.

I have not had chemotherapy for lymphoma.

I have used corticosteroids or optical solutions before my CT scan.

My lymphoma is at an advanced stage and confirmed by a biopsy.

I've had radiation for lymphoma at no more than 2 sites.

I have at least one tumor that can be measured on scans, besides the one biopsied.

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

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

Chemotherapy

Sargramostim

Vaccine Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.

DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

DHA-Paclitaxel for Pancreatic Cancer

This study is evaluating whether a new drug called DHA-paclitaxel is effective in treating people with pancreatic cancer.

I do not have cancer that has spread to my brain.

I do not have an uncontrolled irregular heartbeat.

I do not have a serious infection needing IV treatment.

I do not have any serious health conditions that are not under control.

I have no cancer history except for treated skin cancer, cervical carcinoma in situ, or a cured cancer that hasn't returned in over 5 years.

My cancer spots in areas treated with radiation are not counted as measurable.

I am not receiving any other chemotherapy treatments.

I am not on any hormonal therapy except for megestrol.

I am not receiving any other cancer treatments.

My pancreatic cancer is not a type of lymphoma, sarcoma, or islet cell tumor.

I am fully active or can carry out light work.

I do not have superior vena cava syndrome.

It's been over 2 weeks since my last major surgery and I've recovered.

I will use birth control during and for 6 months after the study.

It's been over 28 days since my last chemotherapy and I've recovered.

It's been over 28 days since my last major radiotherapy and I have recovered.

I have not had a heart attack in the last 3 months.

I haven't had chemotherapy for cancer that has spread.

My pancreatic cancer diagnosis was confirmed through lab tests.

I am not currently undergoing radiotherapy.

My cancer has spread to other parts of my body.

DHA-paclitaxel

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have locally advanced, metastatic, or unresectable kidney cancer.

Chemotherapy in Treating Patients With Metastatic Kidney Cancer

Chemotherapy for Kidney Cancer

This study is evaluating whether a drug called paclitaxel can be used to treat kidney cancer.

My cancer cannot be removed by surgery and has spread.

I have had skin cancer or cervical cancer treated without recurrence, or any cancer treated surgically over 5 years ago without coming back.

My creatinine level is 2.5 mg/dL or lower.

I've been on a stable dose of bisphosphonates for over 30 days and am not on any other cancer treatments.

I do not have any serious or unstable health conditions.

I haven't taken hormonal therapy for at least 28 days and am not currently on it.

It's been over 28 days since my last major radiotherapy session, and I'm not currently undergoing any.

It has been more than 14 days since my last major surgery.

My kidney cancer diagnosis was confirmed through lab tests.

It has been over 28 days since my last immunotherapy, and I am not currently on immunotherapy.

My heart rhythm is normal, and I haven't had a heart attack in the last 3 months.

I haven't had chemotherapy for advanced disease, taxanes, or any chemo in the last 28 days.

I don't have severe nerve damage, uncontrolled seizures, or spinal cord issues.

My liver function tests are within the required limits.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.

DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer

DHA-Paclitaxel for Colorectal Cancer

This study is evaluating whether a new drug called DHA-paclitaxel is effective in treating patients with metastatic colorectal cancer.

I've had only one chemotherapy for my metastatic disease and it wasn't a taxane. It's been over 28 days since my last chemotherapy.

I am not currently on any hormone treatments.

It's been over 28 days since my last major radiotherapy, and I've recovered.

My cancer in the colon or rectum has been confirmed by lab tests.

My kidney function, measured by creatinine, is within normal limits.

I don't have severe nerve damage, uncontrolled seizures, or spinal cord compression.

I have had skin cancer or cervical cancer treated without recurrence, or any cancer treated surgically without recurrence for over 5 years.

I have tried one chemotherapy treatment for my advanced cancer without success.

I am not currently on any immunotherapy treatments.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

DHA-Paclitaxel for Prostate Cancer

This study is evaluating whether a drug called DHA-paclitaxel can stop prostate cancer from growing.

It's been over 28 days since I last used herbal preparations.

My heart rhythm is stable and controlled.

I haven't received nonhormonal treatments for my advanced cancer.

My PSA levels are still high after stopping hormone therapy for prostate cancer.

I am not currently on any hormonal therapy.

I have no other cancers except for treated skin cancer or a cancer cured by surgery over 5 years ago.

I am not taking any other cancer treatments.

I have not received samarium SM 153 or strontium chloride Sr 89 treatments.

I am not currently receiving any form of radiotherapy.

My prostate cancer was confirmed by a lab test.

I have not had surgery to remove my testicles and am continuing hormone therapy.

My cancer has spread and is getting worse despite hormone treatment.

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.

Johns Hopkins Clinical Trials 2022

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