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.

Condition	Treatment or Intervention	Phase
recurrent testicular cancer recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor stage III testicular cancer	Drug: temozolomide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Neurologically 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

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics
• Chemotherapy: See Disease Characteristics
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics
• Surgery: Not specified

--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 least 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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Robert J. Motzer,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000068058; MSKCC-00010; NCI-G00-1817
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00006043
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08