Desmoid Tumor Clinical Trial
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
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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