Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hematologic Neoplasms

Mycoses

Mycosis Fungoides

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, T-Cell, Cutaneous

Lymphoma, Non-Hodgkin

Hematologic Diseases

Lymphosarcoma

Peripheral T-cell Lymphoma

Dermatologic Agents

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Isotretinoin

Interferons

Tretinoin

Interferon-alpha

Interferon-alfa-1b

Interferon alpha-2

Antiviral Agents

Immunologic Factors

0.5 mg/k (1.0 mg/k total) by mouth twice a day

Isotretinoin (Accutane)

Starting dose of 3 MU injected under skin once a day for 12 weeks.

Interferon Alpha

Razelle Kurzrock, MD, BS

The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane).

Retinoids have shown activity in T-cell malignancies in past studies (both isotretinoin and etretinate) with an overall response rate of about 60%. One third of those responses were complete responses. Interferon-alpha has proven efficacy in wide ranges of human malignancies including T-cell lymphomas as a single agent. A clinical trial was needed to evaluate the response rate of these two agents combined.

Interferon is a normal body protein, which is made by cells after exposure to viruses. It acts as a messenger to warn surrounding cells of invasions by viruses and, possibly, by cancer cells. Isotretinoin is a synthetic form of Vitamin A which effects the growth of normal cells and cancer cells.

Participants participating in this study will receive a combination of alpha-interferon and isotretinoin. Alpha-interferon will be given once a day for an initial period of 12 weeks. Participants will take the drug home, where a nurse or family member of the participant (who can be trained at UTMDACC) will inject it just under the skin (SQ). Isotretinoin will be given by mouth twice a day.

If a participant's disease does not show a response, the alpha-interferon and the isotretinoin will be increased. If side effects occur, the dose of alpha-interferon and/or isotretinoin will be decreased by 50%. If the side effects are severe, therapy will be discontinued. If the participant's disease is unresponsive or worsens, the participant will be taken off study and other treatments will be recommended.

Responding participants will be placed on a maintenance schedule for as long as they respond. Up to 60 participants will be studied at UT M.D. Anderson Cancer Center to test the effectiveness of this drug combination.

This is an investigational study. Alpha-interferon and isotretinoin are FDA approved and commercially available.

Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies

Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies

M.D. Anderson Cancer Center

Recurrence

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Carboplatin

Temozolomide

Vorinostat

Antineoplastic Agents, Alkylating

Alkylating Agents

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Vorinostat plus isotretinoin plus temozolomide

Phase I/Arm 1: Level 0 = 300 mg PO x 14 days; Level I = 400 mg PO x 14 days; Level II = 500 mg PO x 14 days.

Phase I/Arm 3: Level -II = 300 mg PO x 14 days; Level -I = 400 mg PO x 14 days; Level 0 = 400 mg PO x 14 days; Level I = 500 mg PO x 14 days.

Phase I/Arm 1: Level 0 = 100 mg/m\^2/day PO x 21 days; Level I = 100 mg/m\^2/day PO x 21 days; Level II = 100 mg/m\^2/day PO x 21 days.

Phase I/Arm 2: Level 0 = 100 mg/m\^2/day PO x 21 days; Level I = 100 mg/m\^2/day PO x 21 days; Level II = 100 mg/m\^2/day PO x 21 days.

Phase I/Arm 3: Level -II = 100 mg/m\^2/day PO x 21 days; Level -I = 100 mg/m\^2/day PO x 21 days; Level 0 = 100 mg/m\^2/day PO x 21 days; Level I = 100 mg/m\^2/day PO x 21 days; Level II = 100 mg/m\^2/day PO x 21 days.

Surgical Resection for recurrent Glioblastoma Multiforme

Surgical Resection

Phase I/Arm 2: All Levels = 150 mg/m2/day PO X 14 days.

Phase I/Arm 3: Level 0 = 150 mg/m2/day PO X 14 days; Level I = 150 mg/m2/day PO X 14 days; Level -I = 125 mg/m2/day PO X 14 days; Level -II = 125 mg/m2/day PO X 14 days; Level -III = 100 mg/m2/day PO X 14 days.

Marta Penas-Prado, MD

Vinay Puduvalli, MD

The goal of this clinical research study is to learn if vorinostat when given with isotretinoin and temozolomide can help to control glioblastoma or gliosarcoma. The safety of these drug combinations will also be studied.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 3 groups. If you are on of the first 30 participants in the study, you will be randomly assigned to a group. If you are enrolled after the first 30 participants, you will be more likely to be enrolled in the group that is showing better results.

* If you are in Group 1, you will take vorinostat and isotretinoin.
* If you are in Group 2, you will take isotretinoin and temozolomide.
* If you are in Group 3, you will take vorinostat, isotretinoin and temozolomide.

Study Drug Administration:

Each study cycle is 28 days.

You will take vorinostat by mouth once a day during Days 1-7 and Days 15-21 of each cycle. You should take vorinostat by mouth in the morning, at about the same time each day. Vorinostat capsules should be swallowed whole and should not be opened. If a capsule is damaged or broken, spills of powder from vorinostat capsules should be cleaned up carefully. If you come in contact with the powder, you should wash your hands thoroughly. If the spill is on a surface, the area must be washed at least 3 times with rubbing alcohol, followed by water. Vorinostat capsules should be stored at room temperature (59°-86°F \[15°-30°C\]) in a dry area. You should take vorinostat with food, but not a high fat meal.

You will also take isotretinoin by mouth 2 times a day on Days 1-21 of each cycle.

You will take temozolomide by mouth once a day on Days 1-7 and Days 15-21 of each cycle. You should take temozolomide by mouth at bedtime, at about the same time each day. You should swallow the temozolomide capsules whole, one right after the other, without chewing them. They should be taken on an empty stomach (at least 2 hours after eating) with 1 cup (about 8 ounces) of water.

If you vomit while taking vorinostat, isotretinoin and/or temozolomide, you should not "make up" the dose. You should wait until the next scheduled dose.

Study Visits:

At Week 2 of every cycle:

° Blood (about 1 teaspoons) will be drawn for routine tests.

At Week 4 of Cycles 1:

* Blood (about 2 teaspoons) will be drawn for routine tests and to check how well your blood clots,.
* If you are able to become pregnant, you will have a blood (about 1/2 teaspoon) pregnancy test.

At Week 4 of Cycle 2 and then every other cycle after that (Cycles 4, 6, 8, and so on):

* You will have a physical exam, including a neurological exam.
* Blood (about 2 teaspoons) will be collected for routine tests. This routine blood draw will also include a pregnancy test if you can become pregnant.
* Blood (about 2 teaspoons) will be drawn to check how well your blood clots, your pancreas function and the amount of fats in your blood.
* You will have a brain MRI scan to check the status of the disease.

At any time during the study, extra tests may be performed if the doctor thinks they are needed for your safety. The study doctor will tell you more about any extra tests.

Length of Study:

You may take the study drug(s) for up to 1 year. You may continue to receive the study drug(s) beyond 1 year if your doctor decides that it is in your best interest. You will be taken off study early if the disease gets worse or you have intolerable side effects.

Long-Term Follow-Up:

After your last dose of the study drug, every 2 months after that, you may be called and asked how you are feeling. This phone call should take about 5-10 minutes.

If you stop the study drugs because of intolerable side effects, you will visit the clinic every 2 months, unless the disease gets worse. At these visits, You will have a physical exam, including a neurological exam.

* Blood (about 2 teaspoons) will be collected for routine tests. This routine blood draw will also include a pregnancy test if you can become pregnant.
* Blood (about 2 teaspoons) will be drawn to check how well your blood clots, your pancreas function and the amount of fats in your blood.
* You will have a brain MRI scan to check the status of the disease.

This is an investigational study. Isotretinoin, temozolomide, and vorinostat are FDA approved drugs and commercially available. The use of these drugs in this combination is investigational.

Up to 135 patients will take part in this study. Up to 30 will be enrolled at MD Anderson.

Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)

Phase I / II Adaptive Randomized Trial of Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme

MTD is dose level at which 1/3 participants shows \> grade 3 toxicity.

Merck Sharp & Dohme LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies	NCT00038376	Lymphoma, T-Cel... Mycosis Fungoid... Hematologic Neo...	Isotretinoin (A... Interferon Alph...	18 Years -	M.D. Anderson Cancer Center
Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM)	NCT00555399	Glioblastoma Mu... Anaplastic Glio...	Vorinostat Isotretinoin Surgical Resect... Temozolomide	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for accutane

Every month we try and update this database with for accutane cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for accutane

Every month we try and update this database with for accutane cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for accutane cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.