Spots Global Cancer Trial Database for Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
Official Title: A Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in Combination With Temozolomide in Patients With Malignant Gliomas
Study ID: NCT00268385
Study Description
Brief 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
National Cancer Institute Neuro-Oncology Branch, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
M D Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Contact Details
Name: Patrick Y Wen
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
