Temozolomide in Treating Patients With Low-Grade Glioma

• Status: Completed
• Trial end date: 2017-06-12
• Target enrollment: 0
• Participant gender: All

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 supratentorial low-grade glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Dacarbazine; Temozolomide

Criteria

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