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Temozolomide in Treating Patients With Recurrent High-Grade Glioma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Temozolomide in Treating Patients With Recurrent High-Grade Glioma

Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma

NCT00619112•University of California, San Francisco

Summary

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.

Detailed Description

OBJECTIVES: Primary * Determine the efficacy, as measured by 6-month progression-free survival, of a dose-intense temozolomide treatment schedule in patients with recurrent high-grade glioma. Secondary * Assess the toxicities of this dose-intense temozolomide. * Determine the overall survival of patients treated with this dose-intense schedule. * Determine whether methylation status of the MGMT gene within patients' tumors predicts greater efficacy (progression-free survival), in patients treated on this protocol. * Determine whether patients' tumors have functional alterations of the mismatch repair (MMR) system by PCR analysis for microsatellite instability (MSI) and whether such alterations may influence outcome in patients treated on this protocol. * Determine how initial success with temozolomide may influence outcome in recurrent patients treated on this protocol by evaluating patients progressing after two first-line adjuvant courses of temozolomide, patients progressing within 6 months after the 6th adjuvant course of temozolomide, and patients progressing 6 months after temozolomide is voluntarily discontinued. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with radiographically proven recurrent, intracranial malignant glioma will be eligible for this protocol.
•All patients must sign an informed consent
•Patients must have had external beam radiation; there is no limit to the number of prior chemotherapies used.
•Patients must be \> 18 years old, and with a life expectancy \> 8 weeks.
•Patients must have a Karnofsky performance status of \> 60.
•At the time of registration: Patients must have recovered from the toxic effects of prior therapy:
•Patients must have adequate bone marrow function.
•Patients must have shown unequivocal radiographic evidence for tumor progression by MRI
•Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: They have recovered from the effects of surgery. Residual disease following resection of recurrent intracranial malignant glioma is not mandated for eligibility into the study.
•Patients must have failed prior radiation therapy and must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry.
+2 more criteria

Exclusion Criteria

•Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
•Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
•Patients must not have active infection or serious intercurrent medical illness.
•Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

December 1, 2011

Completion Date

September 1, 2012

Last Updated

January 31, 2018

Enrollment

ACTUAL participants

Conditions

Recurrent Central Nervous System Neoplasm

Interventions

temozolomide

DRUG

Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme

NCT00890032

Recurrent Central Nervous System Neoplasm

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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