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Spots Global Cancer Trial Database for Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

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Trial Identification

Brief Title: Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

Official Title: Vinblastine and Methotrexate in Children With Desmoid Tumor (Aggressive Fibromatosis) Which is Recurrent or Not Amenable to Surgical Resection or Irradiation - A Pediatric Oncology Group Phase II Study

Study ID: NCT00003019

Conditions

Desmoid Tumor

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Long Beach Memorial Medical Center, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Children's Hospital of Orange County, Orange, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

David Grant Medical Center, Travis Air Force Base, California, United States

Children's Hospital of Denver, Denver, Colorado, United States

Children's National Medical Center, Washington, District of Columbia, United States

University of Chicago Cancer Research Center, Chicago, Illinois, 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

University of Minnesota Cancer Center, Minneapolis, Minnesota, 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

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota, United States

CCOP - Merit Care Hospital, Fargo, North Dakota, United States

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Children's Hospital of Columbus, Columbus, Ohio, United States

Doernbecher Children's Hospital, Portland, Oregon, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

Vanderbilt Cancer Center, Nashville, Tennessee, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

IWK Grace Health Centre, Halifax, Nova Scotia, Canada

Contact Details

Name: Steve Skapek, MD

Affiliation: St. Jude Children's Research Hospital

Role: STUDY_CHAIR

Name: Bruce Himelstein, MD

Affiliation: Children's Hospital of Philadelphia

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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