Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT

Not Recruiting

Trial ID: NCT00084838

Age - N/A-18 Years Condition - Brain (Central Nervous System, CNS) Cancers, Pediatric Cancer Gender - All Accepting Healthy Volunteers - No

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
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

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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

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