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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Centre Paul Papin
Angers, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France
Non-progression rate
Time frame: 3 months
Non-progression rate
Time frame: 12 months
Toxic effects
Time frame: 12 months
Tolerance
Time frame: 12 months
Response rate
Time frame: 5 years
Progression-free survival
Time frame: the time between the inclusion date and the progression date
Overall survival
Time frame: the time between the inclusion date and the death whathever the cause
Quality of life
Time frame: 5 years
Correlation of clinical, biological, and genomic markers with response and long-term stable disease
Time frame: 5 years
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