Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Desmoid Tumor Clinical Trial

Official title: Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy

Status Completed

Clinical Trial Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate.

Secondary

• Determine the non-progression rate in patients after being treated with this drug for 12 months.

• Determine the toxic effects of this drug in these patients.

• Determine the tolerance to this drug in these patients.

• Determine the response rate in patients treated with this drug

• Determine progression free and overall survival of patients treated with this drug.

• Determine the quality of life of patients treated with this drug.

• Correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed periodically.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Desmoid Tumor
• Fibroma

• NCT number: NCT00287846
• Study type: Interventional
• Source: UNICANCER
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2004
• Completion date: June 2010