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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006043
• Other study ID #: 00-010
• Secondary ID: CDR0000068058NCI
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: June 4, 2013
• Start date: February 2000
• Est. completion date: November 2001

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2001
• Est. primary completion date: November 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• temozolomide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,