Vinblastine and Methotrexate in Treating Children With Desmoid Tumors
5 other identifiers
interventional
28
3 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 1997
Longer than P75 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1997
CompletedFirst Submitted
Initial submission to the registry
August 3, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedFirst Posted
Study publicly available on registry
April 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJuly 25, 2014
July 1, 2014
5.9 years
August 3, 2000
July 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Chemotherapy Treatment
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- Children's Cancer Groupcollaborator
Study Sites (39)
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Children's Hospital of Orange County
Orange, California, 92668, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128, United States
David Grant Medical Center
Travis Air Force Base, California, 94535, United States
Children's Hospital of Denver
Denver, Colorado, 80218, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696, United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
IWK Grace Health Centre
Halifax, Nova Scotia, B3J 3G9, Canada
Related Publications (1)
Skapek SX, Ferguson WS, Granowetter L, Devidas M, Perez-Atayde AR, Dehner LP, Hoffer FA, Speights R, Gebhardt MC, Dahl GV, Grier HE; Pediatric Oncology Group. Vinblastine and methotrexate for desmoid fibromatosis in children: results of a Pediatric Oncology Group Phase II Trial. J Clin Oncol. 2007 Feb 10;25(5):501-6. doi: 10.1200/JCO.2006.08.2966.
PMID: 17290057RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steve Skapek, MD
St. Jude Children's Research Hospital
- STUDY CHAIR
Bruce Himelstein, MD
Children's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2000
First Posted
April 30, 2004
Study Start
August 1, 1997
Primary Completion
July 1, 2003
Study Completion
September 1, 2006
Last Updated
July 25, 2014
Record last verified: 2014-07