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

Glioblastoma Multiforme Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Anaplastic Glioma
• Glioblastoma
• Glioblastoma Multiforme
• Glioma

• NCT number: NCT00555399
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 28, 2007
• Completion date: November 20, 2024