Vorinostat + Temozolomide for Brain Cancer

Recruiting in Palo Alto (17 mi)

+18 other locations

Overseen byPatrick Y Wen

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Patrick Y Wen

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for patients with certain types of brain tumors, including glioblastoma and anaplastic astrocytoma. Participants must have a life expectancy over 8 weeks, be able to perform daily activities at least partially independently (Karnofsky score >=60), and have adequate blood cell counts and organ function. Pregnant or breastfeeding women, HIV-positive patients on antiretrovirals, those with recent other cancers or serious illnesses affecting the study's safety are excluded.

Inclusion Criteria

Negative beta-HCG pregnancy test for women of childbearing potential

Agreement to use contraception

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

See 15 more

Exclusion Criteria

I have a history of cancer or blood cell disorders.

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.

See 9 more

Treatment Details

Interventions

Temozolomide (Alkylating Agent)
Vorinostat (Histone Deacetylase Inhibitor)

Trial OverviewThe trial is testing the combination of two chemotherapy drugs: Vorinostat and Temozolomide. It aims to find the safest dose that can effectively treat malignant gliomas by killing tumor cells or stopping their growth. The study will also look into how these drugs affect enzymes related to cell growth.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (vorinostat, temozolomide)Experimental Treatment4 Interventions

PART I: Patients receive vorinostat PO QD or BID on days 1-7 and 15-21 OR QD or BID on days 1-7. Patients also receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Treatment may continue beyond 13 courses at the discretion of the investigator. PART II: Patients receive vorinostat and temozolomide as in part I\*. \[Note: Beginning in course 2, some patients may receive a higher dose of temozolomide.\]