Overview

Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin

Status:
Completed
Trial end date:
2001-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Dacarbazine
Temozolomide
Criteria
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