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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


Phase 2
N/A
21 Years
Not Enrolling
Both
Desmoid Tumor

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steve Skapek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000065601

NCT ID:

NCT00003019

Start Date:

August 1997

Completion Date:

Related Keywords:

  • Desmoid Tumor
  • desmoid tumor
  • Fibromatosis, Aggressive

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
David Grant Medical CenterTravis Air Force Base, California  94535
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105