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| Sponsors and Collaborators: |
Children's Hospital Los Angeles National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006258 |
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 more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: filgrastim Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: methotrexate Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Dose Intensive Chemotherapy for Patients Greater Than or Equal To 10 Years of Age With Newly Diagnosed High Stage Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors (PNET) and Ependymoma: A Feasibility Study of an Intensive Induction Chemotherapy Regimen Followed by Standard Irradiation |
| Study Start Date: | November 1997 |
OBJECTIVES:
OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
Patients then undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of chemotherapy.
Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 10 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histological confirmation of one of the following:
Ependymoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-1320 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Study Chair: | Jonathan L. Finlay, MB, ChB | Children's Hospital Los Angeles |
More Information
| Study ID Numbers: | CDR0000068192, CHLA-NYU-0002H, NYU-0027H, NCI-G00-1852 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006258 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood infratentorial ependymoma childhood supratentorial ependymoma adult medulloblastoma adult myxopapillary ependymoma adult anaplastic ependymoma |
adult ependymoblastoma untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood medulloblastoma newly diagnosed childhood ependymoma adult supratentorial primitive neuroectodermal tumor (PNET) |
|
Antimetabolites Neuroectodermal Tumors, Primitive Immunologic Factors Folate Cyclophosphamide Central Nervous System Neoplasms Etoposide phosphate Vitamin B9 Ependymoma Cisplatin Neoplasms, Germ Cell and Embryonal Methotrexate Neuroepithelioma Glioma Etoposide |
Alkylating Agents Nervous System Neoplasms Adjuvants, Immunologic Vincristine Antimitotic Agents Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Folic Acid Neuroectodermal Tumors Tubulin Modulators Medulloblastoma Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |
|
Antimetabolites Antimetabolites, Antineoplastic Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Reproductive Control Agents Central Nervous System Neoplasms Cyclophosphamide Ependymoma Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Abortifacient Agents Methotrexate Glioma Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Nervous System Neoplasms Neoplasms by Histologic Type Mitosis Modulators Nervous System Diseases Vincristine Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |
