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Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003019
Collaborator
National Cancer Institute (NCI) (NIH), Children's Cancer Group (Other)
28
Enrollment
39
Locations
1
Arm
109
Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 1997
Actual Primary Completion Date :
Jul 1, 2003
Actual Study Completion Date :
Sep 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemotherapy Treatment

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.

Drug: methotrexate
Other Names:
  • MTX
  • amethopterin
  • NSC #000740

    • Drug: vinblastine sulfate
    Other Names:
  • VBL
  • vincaleukoblastine
  • Velban
  • NSC #49842

    		•

    Outcome Measures

    Primary Outcome Measures

    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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically proven, untreated, primary desmoid tumor (aggressive fibromatosis) for which surgery and/or radiation therapy is not thought to be feasible (prior attempted surgical resection allowed if gross residual disease remains) No other fibroblastic lesions or other fibromatoses allowed Recurrent desmoid tumor not previously treated with vinca alkaloids or methotrexate and no chemotherapy since recurrence Measurable disease by MRI

    PATIENT CHARACTERISTICS: Age: Under 19 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin normal for age WBC normal for age Platelet count normal for age Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) for age SGOT less than 1.5 times ULN for age Renal: Creatinine less than 1.5 times ULN for age

    PRIOR CONCURRENT THERAPY: See Disease Characteristics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Long Beach Memorial Medical Center Long Beach California United States 90806
    2 Children's Hospital Los Angeles Los Angeles California United States 90027-0700
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 Children's Hospital of Orange County Orange California United States 92668
    5 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94115-0128
    6 David Grant Medical Center Travis Air Force Base California United States 94535
    7 Children's Hospital of Denver Denver Colorado United States 80218
    8 Children's National Medical Center Washington District of Columbia United States 20010-2970
    9 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    10 Indiana University Cancer Center Indianapolis Indiana United States 46202-5265
    11 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    12 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    13 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    14 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    15 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    16 Children's Mercy Hospital Kansas City Missouri United States 64108
    17 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    18 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    19 NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York United States 10016
    20 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    21 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    22 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    23 Veterans Affairs Medical Center - Fargo Fargo North Dakota United States 58102
    24 CCOP - Merit Care Hospital Fargo North Dakota United States 58122
    25 Children's Hospital Medical Center - Cincinnati Cincinnati Ohio United States 45229-3039
    26 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    27 Children's Hospital of Columbus Columbus Ohio United States 43205-2696
    28 Doernbecher Children's Hospital Portland Oregon United States 97201-3098
    29 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    30 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    31 Vanderbilt Cancer Center Nashville Tennessee United States 37232-6838
    32 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    33 Huntsman Cancer Institute Salt Lake City Utah United States 84132
    34 Children's Hospital and Regional Medical Center - Seattle Seattle Washington United States 98105
    35 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    36 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
    37 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
    38 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    39 IWK Grace Health Centre Halifax Nova Scotia Canada B3J 3G9

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)
    • Children's Cancer Group

    Investigators

    • Study Chair: Steve Skapek, MD, St. Jude Children's Research Hospital
    • Study Chair: Bruce Himelstein, MD, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003019
    Other Study ID Numbers:
    • 9650
    • POG-9650
    • CCG-P9650
    • CDR0000065601
    • COG-P9650
    First Posted:
    Apr 30, 2004
    Last Update Posted:
    Jul 25, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Children's Oncology Group
    desmoid tumor
    Additional relevant MeSH terms:
    Fibromatosis, Aggressive
    Methotrexate
    Vinblastine

    Study Results

    No Results Posted as of Jul 25, 2014