Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
|ClinicalTrials.gov Identifier: NCT00002472|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Pediatric Germ Cell Tumor Extragonadal Germ Cell Tumor||Drug: cisplatin Drug: etoposide Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies|
|Study Start Date :||March 1991|
|Primary Completion Date :||August 2005|
|Study Completion Date :||August 2005|
- Response rate
- Endocrine and cognitive function
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002472
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic - Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Jan C. Buckner, MD||Mayo Clinic|