- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006258
Combination Chemotherapy Followed by Radiation Therapy in Treating Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma
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
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the toxicity of adjuvant dose-intensive induction chemotherapy with cisplatin, vincristine, cyclophosphamide, and etoposide with or without methotrexate followed by standard radiotherapy in patients with surgically resected, newly diagnosed high stage medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.
- Determine the response rate, time to progression, overall survival, and pattern of failure in these patients treated with this regimen.
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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-
-
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California
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Los Angeles, California, United States, 90027-0700
- Children's Hospital Los Angeles
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Pennsylvania
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Danville, Pennsylvania, United States, 17822-1320
- Geisinger Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histological confirmation of one of the following:
- High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater)
- Primitive neuroectodermal tumor
Ependymoma
- Incompletely resected on postoperative MRI or neurosurgical report
- Definitive prior surgery within 42 days of study
PATIENT CHARACTERISTICS:
Age:
- 10 to 65
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGPT less than 2.5 times upper limit of normal
Renal:
- Creatinine clearance greater than 60 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior corticosteroids allowed
- No concurrent corticosteroids as antiemetics
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jonathan L. Finlay, MB, ChB, Children's Hospital Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- adult anaplastic ependymoma
- adult ependymoblastoma
- adult medulloblastoma
- adult myxopapillary ependymoma
- adult supratentorial primitive neuroectodermal tumor (PNET)
- untreated childhood medulloblastoma
- childhood infratentorial ependymoma
- newly diagnosed childhood ependymoma
- childhood supratentorial ependymoma
- untreated childhood supratentorial primitive neuroectodermal tumor
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Ependymoma
- Medulloblastoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Cyclophosphamide
- Etoposide
- Cisplatin
- Methotrexate
- Vincristine
Other Study ID Numbers
- CHLA-NYU-0002H
- CDR0000068192 (Registry Identifier: PDQ (Physician Data Query))
- NYU-0027H
- NCI-G00-1852
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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