©2024 Stanford Medicine
Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT
Not Recruiting
Trial ID: NCT00084838
Purpose
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 than one chemotherapy drug with radiation therapy may kill more
tumor cells.
PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination
chemotherapy together with radiation therapy works in treating young patients with newly
diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.
Official Title
A Phase II Study of Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children With Central Nervous System Atypical Teratoid/Rhabdoid Tumor (AT/RT) Tumor
Stanford Investigator(s)
Paul Graham Fisher, MD
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health
Eligibility
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
Intervention(s):
biological: filgrastim
drug: vincristine sulfate
radiation: radiation therapy
drug: cisplatin
drug: cyclophosphamide
drug: cytarabine
drug: dexrazoxane hydrochloride
drug: doxorubicin hydrochloride
drug: etoposide
drug: leucovorin calcium
drug: methotrexate
drug: temozolomide
drug: therapeutic hydrocortisone
drug: Dactinomycin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paul Fisher
6507258630