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| Sponsored by: |
Children's Hospital of Philadelphia |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031590 |
Purpose
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 |
|
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 |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Cyclophosphamide Etoposide Cisplatin Vincristine sulfate Vincristine Etoposide phosphate Lomustine |
| 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.
Eligibility
| 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:
Contacts and Locations| 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 | |||||
| Children's Hospital of Philadelphia |
| Study Chair: | Peter C. Phillips, MD | Children's Hospital of Philadelphia |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069075, CHP-693, CHP-IRB-2001-12-2301, NCI-V01-1680 |
| First Received: | March 8, 2002 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00031590 |
| Health Authority: | Unspecified |
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