NCT Number: NCT00002472
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
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.
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Conditions
Age range
3 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Histologically proven CNS germ cell tumor of 1 of the following subtypes:
- CNS germinoma
- Immature teratoma
- Embryonal cell carcinoma
- Yolk sac tumor
- Endodermal sinus tumor
- Choriocarcinoma OR
- Pineal or suprasellar mass associated with elevated CSF alpha fetoprotein or beta-human chorionic gonadotropin allowed
- Patients 18 years and over with localized pure germinomas ineligible
- Evaluable CT or MRI of brain and/or spinal cord required
PATIENT CHARACTERISTICS:
Age:
- 3 and over
Hematopoietic:
- Age 18 and over:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
- Under age 18:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 0.3 mg/dL above upper limit of normal for age
Other:
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for CNS germ cell tumor
Endocrine therapy:
- Concurrent corticosteroids allowed except as antiemetics
Radiotherapy:
- No prior cranial or spinal radiotherapy
Surgery:
- Not specified
Treatment and study plan
etoposide
Drugconventional surgery
Procedureneoadjuvant therapy
Procedureradiation therapy
RadiationPrimary outcomes
-
Response rate
-
Survival
-
Endocrine and cognitive function
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies
Important dates
- Study start
- 1991
- Primary completion
- 2005
- Study completion
- 2005
- First posted
- Jan 27, 2003
- Registry last updated
- Mar 15, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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