High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00082797
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Leucovorin may decrease side effects caused by high-dose methotrexate.
PURPOSE: This phase II trial is studying how well giving high-dose methotrexate together with leucovorin works in treating patients with newly diagnosed glioblastoma multiforme.
- Detailed Description
OBJECTIVES:
Primary
* Determine the response in patients with newly diagnosed glioblastoma multiforme treated with high-dose methotrexate and leucovorin calcium.
Secondary
* Determine the acute toxicity of this regimen in these patients.
* Determine the duration of survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive high-dose methotrexate IV over 4 hours on day 1 and oral or IV leucovorin calcium every 6 hours beginning on day 2 and continuing until blood methotrexate levels are acceptable. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients then receive standard radiotherapy with or without chemotherapy. Patients with disease progression proceed to standard radiotherapy with or without chemotherapy upon stopping methotrexate therapy.
Patients are followed at 30 days and then every 2 months for up to 2 years.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (complete and partial)
- Secondary Outcome Measures
Name Time Method Frequency of toxicity
Trial Locations
- Locations (65)
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Hematology and Oncology Associates
🇺🇸Chicago, Illinois, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
🇺🇸Chicago, Illinois, United States
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Swedish Covenant Hospital
🇺🇸Chicago, Illinois, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Northwest Medical Specialist, PC
🇺🇸Niles, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
🇺🇸Maplewood, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Hematology Oncology Associates - Skokie
🇺🇸Skokie, Illinois, United States
Swedish-American Regional Cancer Center
🇺🇸Rockford, Illinois, United States
Midwest Cancer Research Group, Incorporated
🇺🇸Skokie, Illinois, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Hematology/Oncology of the North Shore at Gross Point Medical Center
🇺🇸Skokie, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Park Nicollet Health Services
🇺🇸Saint Louis Park, Minnesota, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
North Shore Oncology and Hematology Associates, Limited - Libertyville
🇺🇸Libertyville, Illinois, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States