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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Testicular Germ Cell Tumor
 Drug: temozolomide
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Temozolomide in Patients With Cisplatin-Refractory Germ Cell Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: February 2000
Study Completion Date: November 2001
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006043

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00006043     History of Changes
Other Study ID Numbers: 00-010, CDR0000068058, NCI-G00-1817
Study First Received: July 5, 2000
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Neoplasms by Histologic Type
Temozolomide
Cisplatin
Dacarbazine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013