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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084838 |
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.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: dactinomycin Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: temozolomide Drug: therapeutic hydrocortisone Drug: vincristine sulfate Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Single-Arm, Open Label Limited-Institutional Phase II Study of Multi-Agent Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children < or = 18 Years With Newly Diagnosed Central Nervous System Atypical Teratoid/Rhabdoid Tumor |
Estimated Enrollment: | 26 |
Study Start Date: | February 2003 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No metastases that disseminate outside the CNS by abdominal and chest CT scans, kidney imaging, and bone marrow biopsy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Stanford Cancer Center | |
Stanford, California, United States, 94305-5826 | |
United States, Connecticut | |
Yale Cancer Center | |
New Haven, Connecticut, United States, 06520-8028 | |
United States, Georgia | |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | |
Chicago, Illinois, United States, 60614 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Children's Hospitals and Clinics of Minnesota - Minneapolis | |
Minneapolis, Minnesota, United States, 55404 | |
United States, Nevada | |
Sunrise Hospital and Medical Center | |
Las Vegas, Nevada, United States, 89109 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Mark W. Kieran, MD, PhD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000365641, DFCI-02294, UTSMC-0403210, JHOC-JHM-IRB5, SUMC-78899, CHP-2003-2-3169, CCF-IRB-6140, CHCM-0302-004 |
Study First Received: | June 10, 2004 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084838 |
Health Authority: | United States: Federal Government |
childhood atypical teratoid/rhabdoid tumor |
Hydrocortisone Rhabdoid Tumor Cortisol succinate Leucovorin Vincristine Central Nervous System Neoplasms Cyclophosphamide Etoposide phosphate Temozolomide Doxorubicin Razoxane |
Rhabdoid tumor Folic Acid Calcium, Dietary Cisplatin Dactinomycin Methotrexate Hydrocortisone acetate Etoposide Nervous System Neoplasms Cytarabine |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibiotics, Antineoplastic Anti-Bacterial Agents Neoplasms by Site Vitamins Therapeutic Uses Abortifacient Agents |
Micronutrients Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Vitamin B Complex Neoplasms by Histologic Type Growth Substances Mitosis Modulators Nervous System Diseases Enzyme Inhibitors Antimitotic Agents Cardiovascular Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |