Active Not Recruiting INTERVENTIONAL NCT00268385

Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas

A Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in Combination With Temozolomide in Patients With Malignant Gliomas

Sponsor: National Cancer Institute (NCI)

Conditions Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Recurrent Adult Brain Neoplasm

Interventions Laboratory Biomarker Analysis Pharmacological Study Temozolomide Vorinostat

Updated 42 times since 2017 Last updated: Apr 9, 2026 Started: Dec 16, 2005 Primary completion: Oct 18, 2018 Completion: Apr 24, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00268385, this observational or N/A phase trial focuses on Adult Anaplastic Astrocytoma and Adult Anaplastic Oligodendroglioma and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 42 times since 2005, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of vorinostat (suberoylanilide hydroxamic acid \[SAHA\]) in combination with temozolomide in patients with malignant gliomas. II. To characterize the safety profile of vorinostat (SAHA) in combination with temozolomide. SECONDARY OBJECTIVES: I. To characterize the pharmacokinetics of vorinostat (SAHA) in combination with temozolomide. II. To determine efficacy of vorinostat (SAHA) in combination with temozolomide as measured by objective response. TERTIARY OBJECTIVES: I. To explore the association of response to treatment to the molecular phenotype of the tumor. II. To assess the effects of vorinostat (SAHA) on histone acetylation status in peripheral mononuclear cells. OUTLINE: This is a 2-part, dose-escalation study of vorinostat. PART I: Patients receive vorinostat orally (PO) once (QD) or twice daily (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. Beginning in course 2, some patients may receive a higher dose of temozolomide. Treatment may continue beyond 13 courses at the discretion of the investigator. PART II: Patients receive vorinostat and temozolomide as in part 1\*....

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of vorinostat (suberoylanilide hydroxamic acid \[SAHA\]) in combination with temozolomide in patients with malignant gliomas.

II. To characterize the safety profile of vorinostat (SAHA) in combination with temozolomide.

SECONDARY OBJECTIVES:

I. To characterize the pharmacokinetics of vorinostat (SAHA) in combination with temozolomide.

II. To determine efficacy of vorinostat (SAHA) in combination with temozolomide as measured by objective response.

TERTIARY OBJECTIVES:

I. To explore the association of response to treatment to the molecular phenotype of the tumor.

II. To assess the effects of vorinostat (SAHA) on histone acetylation status in peripheral mononuclear cells.

OUTLINE: This is a 2-part, dose-escalation study of vorinostat.

PART I: Patients receive vorinostat orally (PO) once (QD) or twice daily (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. Beginning in course 2, some patients may receive a higher dose of temozolomide. Treatment may continue beyond 13 courses at the discretion of the investigator.

PART II: Patients receive vorinostat and temozolomide as in part 1\*.

\[Note: \*Beginning in course 2, all patients receive a higher dose of temozolomide.\]

After completion of study treatment, patients are followed up periodically.

Status Flow

Change History

42 versions recorded

Apr 13, 2026 — Present [daily]

Active Not Recruiting

Phase: PHASE1 → None
Mar 2026 — Present [monthly]

Active Not Recruiting PHASE1
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Feb 2026 — Mar 2026 [monthly]

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▶ Show 37 earlier versions

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Active Not Recruiting PHASE1

First recorded

Dec 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

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.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Baltimore, United States , Bethesda, United States , Birmingham, United States , Boston, United States , Cleveland, United States , Detroit, United States , Durham, United States , Houston, United States , Los Angeles, United States and 7 more locations