Vorinostat + Temozolomide for Brain Cancer

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Antiretrovirals, Valproic acid

Disqualifiers: Other cancers, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 13 months

83 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive vorinostat and temozolomide in a dose-escalation study, with treatment repeating every 28 days for up to 13 courses

Up to 13 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Treatment Details

Interventions

• Temozolomide
• Vorinostat

Trial Overview The 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

Group I: Treatment (vorinostat, temozolomide) Experimental Treatment 4 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\*. \[Note: Beginning in course 2, some patients may receive a higher dose of temozolomide.\]

Temozolomide is already approved in European Union, United States for the following indications:

Approved in European Union as Temodal for:

• Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment
• Children from the age of three years, adolescents and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy

Approved in United States as Temodar for:

• Newly diagnosed glioblastoma concomitantly with radiotherapy and subsequently as monotherapy treatment
• Newly diagnosed or refractory anaplastic astrocytoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+