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

Clinical trial: Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
  PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.

Detailed description: OBJECTIVES:
  -  Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide, carboplatin, and filgrastim (G-CSF).
  -  Determine the toxicity of this treatment regimen in these patients.
  -  Determine the rate of tumor progression in patients treated with this regimen.
  OUTLINE: This is a multicenter study. Patients are stratified according to disease category (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas).
  Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
  PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this study within 4 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma
  -  Residual tumor on postoperative MRI
  -  Bidimensionally measurable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  Under 65
  Performance status:
  -  Karnofsky or Lansky 70-100% OR
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Absolute neutrophil count at least 1,000/mm^3
  -  Hemoglobin at least 8 g/dL (transfusion allowed)
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Bilirubin less than 1.5 times upper limit of normal (ULN)
  -  SGPT no greater than 3 times ULN
  Renal:
  -  Age 5 years and under: Creatinine less than 1.2 mg/dL
  -  Age over 5 to 10 years: Creatinine less than 1.5 mg/dL
  -  Age over 10 to 15 years: Creatinine less than 1.8 mg/dL
  -  Age over 15 years: Creatinine less than 2.4 mg/dL
  Cardiovascular:
  -  No myocardial infarction within the past 6 months
  Other:
  -  No other concurrent serious medical condition that would preclude study
  -  Able to tolerate oral medications
  -  No prior malignancy for which patient received prior chemotherapy or spinal irradiation
  -  No history of severe allergic reaction to platinum-containing compounds
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 72 hours since prior filgrastim (G-CSF)
  Chemotherapy:
  -  No prior chemotherapy
  -  No other concurrent chemotherapy
  Endocrine therapy:
  -  Concurrent steroids for tumor-related cerebral edema allowed
  -  No concurrent corticosteroids for solely antiemetic purposes
  Radiotherapy:
  -  No prior or concurrent radiotherapy
  Surgery:
  -  Recovered from prior surgery
  -  No concurrent surgery

Relevance to patient case: not relevant