Status:
COMPLETED
Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Central Nervous System Tumor, Pediatric
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of intensive systemic and intrathecal chemotherapy and radiotherapy, in terms of medial survival, in children with newly diagnosed central nervous system...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary intracranial Central Nervous System (CNS) atypical teratoid/rhabdoid tumor OR
- Tumor tissue that possesses the INI-1 gene mutation
- No metastases that disseminate outside the CNS by abdominal and chest computer tomography (CT) scans, kidney imaging, and bone marrow biopsy
- No obstruction of cerebrospinal fluid (CSF) flow by CSF flow study
- Definitive surgical resection of tumor within the past 35 days
- PATIENT CHARACTERISTICS:
- Age
- 18 and under
- Performance status
- Karnofsky 50-100% OR
- Lansky 50-100%
- Life expectancy
- Not specified
- Hematopoietic
- Hemoglobin \> 10 g/dL
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 mg/dL
- SGPT \< 10 times normal
- Renal
- Creatinine ≤ 1.5 times normal
- Other
- Willing to have placement of central venous access line
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- Prior steroids allowed
- Radiotherapy
- No prior radiotherapy
- Surgery
- See Disease Characteristics
- Other
- No other prior or concurrent investigational agents
- Concurrent anticonvulsant agents allowed
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00084838
Start Date
February 1 2003
End Date
March 1 2013
Last Update
December 24 2015
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford Cancer Center
Stanford, California, United States, 94305-5826
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
3
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States, 30342
4
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614