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Clinical Trials/NCT00002472
NCT00002472
Completed
Phase 2

Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies

Mayo Clinic3 sites in 1 countryMarch 1991

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Brain and Central Nervous System Tumors
Sponsor
Mayo Clinic
Locations
3
Primary Endpoint
Response rate
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating patients with CNS tumors.

Detailed Description

OBJECTIVES: * Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide. * Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy. * Determine endocrine and cognitive function in these patients before and after receiving this regimen. OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma). Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses, if feasible, and then proceed to radiotherapy. Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy. Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on histology, extent of disease, and response to chemotherapy. Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 years.

Registry
clinicaltrials.gov
Start Date
March 1991
End Date
August 2005
Last Updated
15 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Response rate

Survival

Endocrine and cognitive function

Study Sites (3)

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