Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have recurrent or progressive malignant glioma.

Detailed description: OBJECTIVES:
  -  Determine the progression-free survival and response rate of patients with recurrent or progressive malignant glioma treated with temozolomide.
  -  Determine whether certain categories of malignant gliomas, such as oligodendroglioma, are more sensitive to temozolomide.
  -  Determine the toxicity of this regimen in these patients.
  OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent anaplastic oligodendroglioma).
  Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven recurrent or progressive malignant glioma of one of the following types:
  -  Anaplastic oligodendroglioma or oligoastrocytoma
  -  Anaplastic astrocytoma
  -  Glioblastoma multiforme (stratum closed to accrual 11/30/01)
  -  Patients who have failed radiotherapy are eligible
  -  Measurable disease by CT scan or MRI
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 70-100%
  Life expectancy:
  -  At least 12 weeks
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,500/mm^3
  -  Platelet count greater than 100,000/mm^3
  -  Hemoglobin greater than 10 g/dL
  Hepatic:
  -  SGOT or SGPT less than 3 times upper limit of normal (ULN)
  -  Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma glutamyl transferase test must be performed)
  Renal:
  -  BUN less than 1.5 times ULN
  -  Creatinine less than 1.5 times ULN
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective barrier contraception
  -  No other serious concurrent infection or other medical illness that would preclude study entry
  -  No frequent vomiting or partial bowel obstruction
  -  HIV negative
  -  No AIDS-related illness
  -  No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No concurrent epoetin alfa
  Chemotherapy:
  -  At least 6 weeks since other prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 3 months since prior radiotherapy (exceptions allowed for recurrent/progressive disease at discretion of primary investigator)
  Surgery:
  -  Recovered from prior surgery
  Other:
  -  No other concurrent investigational agents
  -  Concurrent anticonvulsant therapy allowed

Relevance to patient case: not relevant