Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Temozolomide in Treating Patients With Low-Grade Glioma

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.

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 the safety profile of temozolomide in patients with supratentorial low-grade glioma.
  -  Assess the time to tumor progression in patients treated with temozolomide.
  OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: 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

Relevance to patient case: not relevant