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Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Registration Number
NCT00003309
Lead Sponsor
Eastern Cooperative Oncology Group
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (14)

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

🇺🇸

Nashville, Tennessee, United States

Medical College of Wisconsin Cancer Center

🇺🇸

Milwaukee, Wisconsin, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

CCOP - Cedar Rapids Oncology Project

🇺🇸

Cedar Rapids, Iowa, United States

Veterans Affairs Medical Center - Lakeside Chicago

🇺🇸

Chicago, Illinois, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

🇺🇸

Chicago, Illinois, United States

CCOP - Kalamazoo

🇺🇸

Kalamazoo, Michigan, United States

West Michigan Cancer Center

🇺🇸

Kalamazoo, Michigan, United States

CCOP - Metro-Minnesota

🇺🇸

Saint Louis Park, Minnesota, United States

CCOP - Marshfield Clinic Research Foundation

🇺🇸

Marshfield, Wisconsin, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

CCOP - Iowa Oncology Research Association

🇺🇸

Des Moines, Iowa, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

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