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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00006043
First received: July 5, 2000
Last updated: June 4, 2013
Last verified: June 2013

July 5, 2000
June 4, 2013
February 2000
November 2001   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00006043 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Temozolomide in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to Cisplatin
Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
Drug: temozolomide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2001
November 2001   (final data collection date for primary outcome measure)

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

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006043
00-010, CDR0000068058, NCI-G00-1817
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP