- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003309
Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer
A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
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 and 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 adult patients with brain cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy.
- Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation.
- Determine the toxic effects associated with this treatment in these patients.
OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
-
Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Chicago, Illinois, United States, 60611-4494
- Veterans Affairs Medical Center - Lakeside Chicago
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Michigan
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Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232-6307
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Clinic Research Foundation
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Milwaukee, Wisconsin, United States, 53226-3596
- Medical College of Wisconsin Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
Histologically confirmed central nervous system cancer including:
- Medulloblastoma with either local residual disease of greater than 1 cm^2 on MRI following resection or evidence of metastases (M1-4)
- Other primitive neuroectodermal tumors
- Ependymoma with evidence of subarachnoid metastases
- Must have less than 1 cm of midline shift or no acute elevated intercranial pressure
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 125,000/mm^3
- Hemoglobin greater than 10 g/dL
- No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Hepatic:
- Bilirubin less than 2 times upper limit of normal (ULN)
- SGOT less than 2 times ULN
- Alkaline phosphatase less than 2 times ULN
- No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Renal:
- Creatinine greater than 70 mL/min
- No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Pulmonary:
- No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted
- No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up
Other:
- No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up
- No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No increasing doses of steroids for intracranial disease within 3 days of registration
Radiotherapy:
- No prior radiotherapy
Surgery:
- 10-28 days since prior surgical resection OR
- At least 5 days since prior biopsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Paul L. Moots, MD, Vanderbilt-Ingram Cancer Center
- Study Chair: Larry Kleinberg, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study Chair: Geoffrey R. Barger, MD, Barbara Ann Karmanos Cancer Institute
Publications and helpful links
General Publications
- Moots PL, O'Neill A, Barger GR, et al.: Toxicities associated with chemotherapy followed by craniospinal radiation for adults with poor-risk medulloblastoma/PNET and disseminated ependymoma: a preliminary report of ECOG 4397. [Abstract] J Clin Oncol 22 (Suppl 14): A-1573, 125s, 2004.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Ependymoma
- Medulloblastoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- 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
- Cyclophosphamide
- Etoposide
- Vincristine
Other Study ID Numbers
- CDR0000066256
- E4397
- SWOG-E4397
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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