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 metastatic germ cell tumors that have not responded to cisplatin.
OBJECTIVES: I. Determine the efficacy of temozolomide in patients with cisplatin refractory
metastatic germ cell tumors. II. Determine the safety of this treatment in these patients.
OUTLINE: Patients receive oral temozolomide on days 1-5. Treatment repeats every 28 days for
a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study over 25 months.
DISEASE CHARACTERISTICS: Histologically confirmed metastatic germ cell tumor Seminoma OR
Nonseminoma Measurable disease Abnormalities on radiograph OR Alpha fetoprotein greater
than 15 ng/mL OR Beta human chorionic gonadotropin greater than 2.2 mIU/L At least one
measurable disease site that has not received prior radiotherapy Refractory to prior
cisplatin and failed, not eligible for, or refused autologous bone marrow transplantation
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil
count at least 1,000/mm3 Platelet count at lest 80,000/mm3 Hemoglobin at least 10 g/dL
Hepatic: Bilirubin no greater than 1.5 times normal Transaminases no greater than 1.5
times upper limit or normal (ULN) Alkaline phosphatase no greater than 3.0 times ULN
Renal: Creatinine no greater than 1.5 times ULN Other: No medical conditions that would
interfere with swallowing or cause excessive vomiting No second malignancy except basal
and squamous cell skin cancer Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics Surgery: Not specified