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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
21 Years
Not Enrolling
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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steve Skapek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

  • Desmoid Tumor
  • desmoid tumor
  • Fibromatosis, Aggressive



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