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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00002472 |
Purpose
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 | Intervention | 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 II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies |
| Study Start Date: | March 1991 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven CNS germ cell tumor of 1 of the following subtypes:
PATIENT CHARACTERISTICS:
Age:
Hematopoietic:
Age 18 and over:
Under age 18:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Jan C. Buckner , MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00002472 History of Changes |
| Other Study ID Numbers: | CDR0000076756, P30CA015083, 891351, T92-0208D |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 14, 2011 |
| Health Authority: | United States: Federal Government |
|
childhood central nervous system germ cell tumor extragonadal germ cell tumor adult central nervous system germ cell tumor childhood teratoma childhood central nervous system choriocarcinoma |
childhood central nervous system embryonal tumor childhood central nervous system germinoma childhood central nervous system mixed germ cell tumor childhood central nervous system teratoma childhood central nervous system yolk sac tumor |
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms by Histologic Type Etoposide phosphate |
Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
