Clinical Trial: Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vinblastine and Methotrexate in Children With Desmoid Tumor (Aggressive Fibromatosis) Which is Recurrent or Not Amenable to Surgical Resection

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.


Detailed Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: August 3, 2000
Date Started: August 1997
Date Completion:
Last Updated: July 24, 2014
Last Verified: July 2014