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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin  Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
For Condition: stage 3 testicular cancer,recurrent ovarian germ cell tumor,stage 4 ovarian germ cell tumor,recurrent testicular cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068058; MSKCC-00010,NCI-G00-1817
Study Start Date: February 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006043
Other Recurrent Testicular Cancer Studies:
1. Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
2. Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors
3. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
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Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
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