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 brain metastases.
- Determine the activity of temozolomide in patients with brain metastases.
- Determine the toxicity of this treatment in these patients.
OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs
breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs
Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28
days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.
- Metastatic lesions to the brain
- Must not require immediate radiotherapy
- If received prior radiotherapy, must have progressive disease
- Evaluable disease by CT scan or MRI
- Neurologically stable
- 18 and over
- Karnofsky 70-100%
- More than 12 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT or SGPT less than 2.5 times ULN
- Alkaline phosphatase less than 2 times ULN
- Blood urea nitrogen less than 1.5 times ULN
- Creatinine less than 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent nonmalignant systemic disease
- No acute infection requiring treatment with IV antibiotics
- HIV negative
- No frequent vomiting or medical condition that would preclude oral medication
administration (e.g., partial bowel obstruction, inability to swallow)
PRIOR CONCURRENT THERAPY:
- No concurrent hematopoietic growth factors, including epoetin alfa
- No other concurrent biologic therapy
- At least 4 weeks since prior chemotherapy, unless evidence of disease progression
- No other concurrent chemotherapy
- Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease
- No concurrent radiotherapy
- At least 3 weeks since prior surgery, unless evidence of disease progression, and
- No other concurrent investigational drugs