Status:
COMPLETED
Temozolomide in Treating Patients With Low-Grade Glioma
Lead Sponsor:
University of California, San Francisco
Conditions:
CNS Tumor, Adult
Eligibility:
All Genders
18-120 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 of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma. Secondary * Assess t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven supratentorial low-grade (grade II) glioma of any of the following histologic subtypes:
- Oligodendroglioma
- Astrocytoma
- Oligoastrocytoma
- Has undergone surgical resection or biopsy within 35 days after diagnosis of low-grade glioma
- Study treatment must begin between 14 days and 4 months after surgical resection or biopsy
- Evaluable disease by gadolinium-MRI
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Creatinine \< 1.5 times upper limit of normal (ULN)
- BUN \< 1.5 times ULN
- Bilirubin \< 1.5 times ULN
- SGOT \< 2.5 times ULN
- Alkaline phosphatase \< 2 times ULN
- Life expectancy \> 12 weeks
- No nonmalignant systemic disease resulting in the patient being a poor medical risk
- No acute infection requiring intravenous antibiotics
- No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction)
- No other concurrent malignancies except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- Prior malignancies must be in remission for ≥ 5 years
- No known HIV positivity
- No AIDS-related illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy, interstitial brachytherapy, or radiosurgery for low-grade glioma
- No prior biological therapy or chemotherapy for low-grade glioma
- No other concurrent chemotherapy
- No concurrent radiotherapy or biological therapy
- No concurrent prophylactic growth factors
- No concurrent epoetin alfa
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00313729
Start Date
May 1 1999
End Date
June 12 2017
Last Update
February 7 2019
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115