Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies
Verified date | March 2011 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic - Jacksonville | Jacksonville | Florida |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | No | ||
Primary | Survival | No | ||
Primary | Endocrine and cognitive function | No |
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