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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031590 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining low-dose radiation therapy with combination chemotherapy may be effective in treating primitive neuroectodermal tumor and medulloblastoma.
PURPOSE: This phase II trial is studying giving low-dose radiation therapy together with combination chemotherapy after surgery to see how well it works in treating children with newly diagnosed primitive neuroectodermal tumor or medulloblastoma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: lomustine Drug: vincristine sulfate Procedure: adjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Study Of Reduced Dose Craniospinal Radiotherapy (1800 cGy) And Chemotherapy In Children With Newly-Diagnosed Standard-Risk Posterior Fossa Primitive Neuro-Ectodermal Tumor (PNET/Medulloblastoma) |
Estimated Enrollment: | 50 |
Study Start Date: | April 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Maintenance chemotherapy: Beginning 4 weeks after the completion of induction chemoradiotherapy, patients receive two 6-week courses of regimen A as outlined below alternated with one 6-week course of regimen B as outlined below for a total of 9 courses (6 courses of regimen A and 3 courses of regimen B).
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 3 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Standard-risk disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, California | |
Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Paul G. Fisher, MD, MHS 650-497-8953 pfisher@stanford.edu | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Egleston, Georgia, United States, 30322 | |
Contact: Anna J. Janss, MD, PhD 404-257-3480 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4318 | |
Contact: Peter C. Phillips, MD 215-590-3129 |
Study Chair: | Peter C. Phillips, MD | Children's Hospital of Philadelphia |
Responsible Party: | Children's Hospital of Philadelphia ( Peter C. Phillips ) |
Study ID Numbers: | CDR0000069075, CHP-693, CHP-IRB-2001-12-2301, NCI-V01-1680 |
Study First Received: | March 8, 2002 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00031590 |
Health Authority: | Unspecified |
untreated childhood medulloblastoma |
Neuroectodermal Tumors, Primitive Lomustine Vincristine Central Nervous System Neoplasms Cyclophosphamide Etoposide phosphate Neuroectodermal Tumors Cisplatin |
Neoplasms, Germ Cell and Embryonal Medulloblastoma Neuroepithelioma Glioma Etoposide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |