Vinblastine and Methotrexate in Treating Children With Desmoid Tumors
- Registration Number
- NCT00003019
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and methotrexate in treating children who have desmoid tumors that are recurrent or untreatable with surgery or radiation therapy.
- Detailed Description
OBJECTIVES: I. Estimate the efficacy and toxicity of vinblastine and methotrexate for newly diagnosed or recurrent desmoid tumors in children who are not good candidates for treatment with surgery or radiation therapy.
OUTLINE: Patients receive vinblastine and methotrexate IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 13-25 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy Treatment vinblastine sulfate Patients receive vinblastine sulfate (5 mg/m2) IV and methotrexate (30 mg/m2) IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter. Chemotherapy Treatment methotrexate Patients receive vinblastine sulfate (5 mg/m2) IV and methotrexate (30 mg/m2) IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter.
- Primary Outcome Measures
Name Time Method Event Free Survival To estimate the efficacy and toxicity of vinblastine and methotrexate for desmoid tumor in children with newly diagnosed or recurrent desmoid tumor who are not good candidates for treatment with surgery or radiation therapy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Fargo
🇺🇸Fargo, North Dakota, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
IWK Grace Health Centre
🇨🇦Halifax, Nova Scotia, Canada
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Children's Hospital of Columbus
🇺🇸Columbus, Ohio, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Children's Hospital of Denver
🇺🇸Denver, Colorado, United States
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Children's Hospital Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States