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Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors

Phase 2
16 Years
Not Enrolling
Ovarian Cancer, Testicular Germ Cell Tumor

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Trial Information

Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

November 2001

Related Keywords:

  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • stage III malignant testicular germ cell tumor
  • recurrent malignant testicular germ cell tumor
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal



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