Status:
COMPLETED
Temozolomide in Treating Patients With Recurrent High-Grade Glioma
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Central Nervous System Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pha...
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. Secon...
Eligibility Criteria
Inclusion
- 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.
- Patients with prior therapy that included interstitial brachytherapy, stereotactic radiosurgery, or Gliadel wafers must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or MR spectroscopy or surgical documentation of disease.
- Male and female patients with reproductive potential must use an approved contraceptive method
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00619112
Start Date
October 1 2007
End Date
September 1 2012
Last Update
January 31 2018
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115