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.

The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.

Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

Adefovir + Nelfinavir for HIV

This study is evaluating whether it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.

My child has been on a stable HIV medication regimen for at least 2 weeks.

My child is between 3 months and 16 years old.

My child has had an AIDS-related infection.

My child does not have any illness that would stop them from finishing the study.

My child has been on protease inhibitors at the start of this study.

My child has not used or is willing to stop using certain HIV medications for the study.

Adefovir Dipivoxil

Nelfinavir

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

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 metastatic, recurrent, or unresectable cancer of the esophagus.

Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus

Paclitaxel for Esophageal Cancer

This study is evaluating whether paclitaxel is effective in treating esophageal cancer.

I haven't had chemotherapy in the last 4 weeks.

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 heart condition does not severely limit my daily activities.

I have had only one chemotherapy treatment before.

I haven't had radiotherapy in the last 4 weeks.

My cancer mainly affects my esophagus or where my stomach meets my esophagus.

I have not received treatment for cancer that has spread.

My cancer is a type of esophageal cancer that cannot be removed by surgery.

I have had only one chemotherapy or radiation treatment before surgery or additional therapy.

I had skin cancer treated with the goal of curing it.

My cervical cancer was treated with the intent to cure.

Less than 30% of my bone marrow has been exposed to radiation.

I am not currently undergoing radiotherapy.

I do not have serious heart fluid buildup or irregular heartbeat.

My cancer can be measured or seen on tests.

I do not have any serious infections or illnesses.

My stomach cancer has barely spread to the junction or lower esophagus.

My cancer has not spread to the bones only.

I haven't had immunotherapy in the last 4 weeks.

I am not currently on any immunotherapy treatments.

I haven't had hormonal therapy in the last 4 weeks.

I have not had any surgery in the last 2 weeks.

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

Paclitaxel

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

High-Dose Interferon Alfa for Melanoma

This study is evaluating whether interferon alfa can improve survival for people with melanoma.

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.

My cancer is stage III with a tumor thicker than 4mm or has spread to one lymph node.

Interferon alfa-2b

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

Purpose: This protocol proposes a safety and feasibility trial in patients with metastatic prostate cancer (stages D1-D3) investigating the induction of antitumor immunity by administration of cultured autologous peripheral blood precursor derived dendritic cells (DC), transfected with mRNA amplified from autologous prostate tumor tissue. The feasibility and dose-limiting toxicity of administering escalating doses of tumor RNA transfected dendritic cells will be defined. As a secondary endpoint, the ability of tumor RNA transfected dendritic cells to induce tumor-specific immune responses will be evaluated. Finally, the anti-tumor effect based on PSA (biochemical) response criteria will be defined.

Background: Because prostate cancer is incurable when metastatic and conventional therapies do not offer a clear survival benefit, new therapeutic strategies are warranted. This study is based on the premise that clinically effective cell mediated immune responses against prostate tumors can be elicited by activation of tumor associated antigen specific T cells. Work performed by others and our group suggests that PSA, a protein expressed in virtually all prostate cancers, can serve as a widely expressed candidate antigen for prostate cancer immunotherapy. In particular, we have shown that cultured dendritic cells transfected with mRNA encoding PSA are remarkably effective in stimulating antigen specific immunity in vitro. Therefore, we hypothesize that administration of PSA RNA transfected DC will lead to detectable levels of PSA specific CTL in the peripheral blood of patients with PSA expressing metastatic prostate cancer. It is hoped that these T cell responses also have clinical antitumor activity.

A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

Dendritic Cell Immunotherapy for Prostate Cancer

This study is evaluating whether a vaccine made from a patient's own cells can help treat prostate cancer.

I cannot undergo leukapheresis due to poor vein access.

I have prostate cancer that has spread to other parts of my body, but it's not small cell or transitional cell cancer.

I have a history of autoimmune diseases like lupus or multiple sclerosis.

I've had a 4-week break (12 weeks if treated with 89-Strontium) from any cancer treatment and recovered from side effects.

I have another cancer besides non-melanoma skin cancer or superficial bladder cancer.

I currently have an infection, such as a UTI, HIV, or hepatitis.

I am not currently on steroids or immunosuppressants, or it has been 6 weeks since I stopped.

I have a serious illness like severe heart, lung, or liver disease that makes treatment risky.

My kidney and liver are functioning well.

I stopped taking my hormone therapy for prostate cancer 4 weeks ago due to rising PSA levels.

I can understand and sign the consent form as per the guidelines.

I am mostly able to care for myself and carry out normal activities.

I have brain metastases from my cancer, previously treated or new.

I am on hormone therapy for cancer with testosterone levels below 50 mg/l.

Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

The feasibility and dose-limiting toxicity of administering escalating doses of dendritic cells transfected with autologous renal cell carcinoma RNA DC(DCRCC-RNA) will be defined. As a secondary endpoint, the ability of DCRCC-RNA to induce tumor-specific immune responses will be evaluated. Finally, the anti-tumor effects measured by clinical response criteria, their duration and overall survival (calculated at 2-year follow-up) will be determined in each patient receiving dendritic cell therapy.

Background: Prognosis in metastatic renal cell carcinoma is poor with a median survival of less than one year. Although renal cell carcinoma has shown some response to immunotherapy, the results of systemic administration of biologic response modifiers in disseminated renal cell carcinoma have been poor. Growing evidence suggests that active immunotherapy, particularly dendritic cells (DC) based vaccines, may prove to be a viable and clinically effective therapeutic option for patients with advanced or metastatic renal cell carcinoma.

Active Immunotherapy Of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA

Immunotherapy for Kidney Cancer

This study is evaluating whether a vaccine made from a patient's own cancer cells can help treat cancer.

I have not had a complete kidney removal surgery.

I have not taken steroids or other immune-suppressing drugs in the last 6 weeks.

I haven't had any cancer except for minor skin cancers or early-stage bladder cancer in the last 5 years.

I had surgery to remove a kidney tumor and it has spread.

I can receive blood transfusions to meet the study requirements.

I do not have any active infections or complications that would make treatment risky.

I can care for myself and doctors expect me to live 6 months or more.

I haven't had major surgery or cancer treatments in the last 6 weeks and have recovered from any side effects.

My kidney and liver tests are within normal limits.

My calcium levels are high or I have symptoms of high calcium, but I am receiving treatment for it.

I have brain metastases, confirmed by a CT or MRI scan.

I have a history of autoimmune disease like lupus or multiple sclerosis.

Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA

Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response.

Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.

Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer

Doxil + Hyperthermia for Breast Cancer

This study is evaluating whether a combination of chemotherapy and heat treatment is more effective than chemotherapy alone for treating breast cancer.

My breast cancer has returned or spread to other parts.

Doxil

Hyperthermia

All Individual Drugs Already Approved

Approved for 30 Other Conditions

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

Chemotherapy + Monoclonal Antibody Therapy for Non-Hodgkin's Lymphoma

This study is evaluating whether a combination of 2 monoclonal antibodies plus chemotherapy is more effective than a combination of 2 monoclonal antibodies plus chemotherapy in treating patients with newly diagnosed non-Hodgkin's lymphoma.

I have never received monoclonal antibody treatment for cancer.

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

I have been diagnosed with congestive heart failure.

I have been diagnosed with cardiomyopathy.

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

I have not had radiation therapy for lymphoma.

I have not had chemotherapy for lymphoma before.

My condition is graded between I and III.

I can take care of myself and am up and about more than half of my waking hours.

I have a type of lymphoma that has not been treated and is in an advanced stage.

Cyclophosphamide

Doxorubicin

Rituximab

Tositumomab

Vincristine

The primary objective of this multi-center sub-study of USPHS Study 23: "Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid with Daily Efavirenz in Combination with Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections," is to compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz. Secondary objectives are: (1) To describe pharmacokinetics of both rifabutin and efavirenz in combination regimen, (2) To evaluate the safety of concomitant efavirenz and rifabutin, (3) To assess the effect on absolute neutrophil count by changing rifabutin dose and adding efavirenz to the regimen, (4) To develop models of optimal sampling times for rifabutin dosed twice a week, (5) To describe the pharmacokinetics of isoniazid in combination with efavirenz daily with two NRTIs, (6) To compare the pharmacokinetics of isoniazid with and without efavirenz.

Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Rifabutin + Isoniazid +/- Efavirenz for HIV-Related Tuberculosis

This study is evaluating whether a combination of rifabutin and efavirenz is safe and effective.

I am willing to start a specific HIV treatment as outlined by the study.

I am part of Study 23 or I have HIV with confirmed or suspected tuberculosis.

I am not taking any protease inhibitors or specific medications listed in the study protocol.

I am a woman who can have children and agree to use birth control and take a pregnancy test before joining.

I am currently on tuberculosis treatment but not on HIV medication.

Efavirenz

Isoniazid

Rifabutin

Approved for 10 Other Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

Combination Chemotherapy for Ewing's Sarcoma

This study is evaluating whether a combination of chemotherapy and radiation therapy is more effective than chemotherapy alone in treating Ewing's sarcoma.

My cancer is a type of Ewing's sarcoma or related.

My disease is either operable, was operated on, needs or doesn’t need immediate radiotherapy, has spread to lungs/pleura or beyond, and it’s been less than 45 days since my definitive biopsy.

My kidney function is normal, with a filtration rate of 60 mL/min or more.

My heart functions normally, with good pumping ability.

I don't have any health or social issues that would stop me from joining the study.

Duke Clinical Trials 2022

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