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| Sponsors and Collaborators: |
Pediatric Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003573 |
Purpose
RATIONALE: Drugs used in chemotherapy use 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. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: vincristine sulfate Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 1998 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Compare the response rate and toxicity of these patients to historical control patients registered on POG
OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).
Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2 years.
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 106 Study Locations| Study Chair: | Albert Moghrabi, MD | Hopital Sainte Justine |
More Information
| Study ID Numbers: | CDR0000066640, POG-9631 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003573 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated childhood medulloblastoma |
|
Neuroectodermal Tumors, Primitive Immunologic Factors Adjuvants, Immunologic Vincristine Antimitotic Agents Central Nervous System Neoplasms Cyclophosphamide Immunosuppressive Agents Etoposide phosphate Neuroectodermal Tumors Cisplatin Neoplasms, Germ Cell and Embryonal |
Tubulin Modulators Medulloblastoma Neuroepithelioma Antineoplastic Agents, Alkylating Glioma Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Etoposide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Cyclophosphamide Etoposide phosphate Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Alkylating Agents Etoposide |
Nervous System Neoplasms Neoplasms by Histologic Type Mitosis Modulators Nervous System Diseases Vincristine Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Tubulin Modulators Myeloablative Agonists Medulloblastoma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial |
