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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00619112 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with recurrent high-grade glioma.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: temozolomide Procedure: DNA methylation analysis Procedure: laboratory biomarker analysis Procedure: microsatellite instability analysis Procedure: polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma |
Estimated Enrollment: | 60 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and days 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded tissue blocks or unstained paraffin slides from available surgical samples are evaluated for molecular abnormalities in the tumor, including (but not limited to) MGMT status and microsatellite instability.
After completion of study therapy, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 40 patients with WHO II grade 4 tumors (glioblastoma multiforme [GBM]) and 20 patients with WHO II grade 3 tumors (non-GBM) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiographically proven recurrent intracranial malignant glioma, including any of the following subtypes:
Must show unequivocal radiographic evidence of tumor progression by MRI or CT scan while on a stable dose of steroids for ≥ 5 days
Must have received prior treatment with ≥ 1 course of standard adjuvant 5-day dose schedule of temozolomide
Patients having undergone recent resection of recurrent or progressive tumor are eligible provided all of the following conditions apply:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 |
Principal Investigator: | Nicholas A. Butowski, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Principal Investigator: | Susan M. Chang, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000572434, UCSF-H44867-31182-01, UCSF-07107, SPRI-UCSF-H44867-31182-01 |
Study First Received: | February 19, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00619112 |
Health Authority: | Unspecified |
adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma |
adult anaplastic oligodendroglioma adult mixed glioma recurrent adult brain tumor |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |