Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00268385
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Temozolomide — DRUG
    Given orally
  • Vorinostat — DRUG
    Given orally

Study Details

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.

Key Dates

Start date
Dec 16, 2005
Status verified
Feb 2026
Primary completion
Oct 18, 2018
Completion
Apr 24, 2027

Study Design

Enrollment
83 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

MTD of vorinostat with temozolomide defined as the dose at which less than one-third of patients experience dose-limiting toxicity based on the CTC severity grading (Part I) [ Time Frame: 28 days ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
Moffitt Cancer CenterTampaFlorida33612-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
National Cancer Institute Neuro-Oncology BranchBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford HospitalDetroitMichigan48202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44195-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALUCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUCSF Medical Center-Mount Zion· San Francisco, CAMoffitt Cancer Center· Tampa, FLEmory University Hospital/Winship Cancer Institute· Atlanta, GAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MD

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