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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00653068 |
RATIONALE: Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
PURPOSE: This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: etoposide phosphate Drug: filgrastim Drug: methotrexate Drug: thiotepa Drug: vincristine sulfate Procedure: 3-dimensional conformal radiation therapy Procedure: autologous hematopoietic stem cell transplantation Procedure: immunohistochemistry staining method Procedure: mutation analysis Procedure: peripheral blood stem cell transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation |
Estimated Enrollment: | 70 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of CNS atypical teratoid/rhabdoid tumor (AT/RT) or tumors that have a mutation of the INI1 gene (even if the tumor does not have the usual histologic characteristics of AT/RT)
Cranial MRI (with and without gadolinium) must be done pre-operatively
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior radiotherapy or chemotherapy except for the following:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer 205-934-0309 | |
United States, California | |
Children's Hospital Central California | Recruiting |
Madera, California, United States, 93638-8762 | |
Contact: Vonda L. Crouse 559-353-5480 |
Principal Investigator: | Alyssa T. Reddy, MD | Children's Hospital of Alabama at University of Alabama at Birmingham |
Study ID Numbers: | CDR0000592812, COG-ACNS0333 |
Study First Received: | April 3, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00653068 |
Health Authority: | Unspecified |
childhood atypical teratoid/rhabdoid tumor |
Rhabdoid Tumor Vincristine Central Nervous System Neoplasms Cyclophosphamide Carboplatin Etoposide phosphate Rhabdoid tumor |
Thiotepa Folic Acid Cisplatin Methotrexate Etoposide Nervous System Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators |
Nervous System Diseases Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Neoplasms, Complex and Mixed |