Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Desmoid Tumor

Intervention / Treatment
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* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed aggressive fibromatosis (desmoid tumor) Relapse or disease progression despite surgery, chemotherapy, radiotherapy, or any other treatment Tumors must meet the following criteria: Ineligible for complete surgical resection by carcinological exeresis OR surgery would cause severe mutilation Cannot be treated with curative radiotherapy Measurable disease by RECIST criteria No prior malignancy PATIENT CHARACTERISTICS: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after completion of study treatment Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Bilirubin < 1.5 times upper limit of normal (ULN) SGOT and SGPT < 2.5 times ULN Creatinine ≤ 2.5 times normal No severe liver failure No chronic somatic or psychiatric illness that would preclude study compliance No known hypersensitivity to imatinib mesylate or one of its components No geographical, social, or psychological reason that would inhibit follow-up PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent immunomodulators* No concurrent hormonal treatments* if used for fibromatosis No concurrent cytotoxic drugs* No concurrent nonsteroidal anti-inflammatory drug* if used for fibromatosis Allowed if used as an analgesic 3 months prior to disease progression No concurrent participation in another therapeutic investigational trial NOTE: *If disease progression has occurred during this treatment, then the treatment must have ended ≥ 1 month prior to study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib<br>400 to 800 mg/day for a maximal 12 months study duration. | Drug: imatinib mesylate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-progression rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-progression rate |  | 12 months | 
| Toxic effects |  | 12 months | 
| Tolerance |  | 12 months | 
| Response rate |  | 5 years | 
| Progression-free survival |  | the time between the inclusion date and the progression date | 
| Overall survival |  | the time between the inclusion date and the death whathever the cause | 
| Quality of life |  | 5 years | 
| Correlation of clinical, biological, and genomic markers with response and long-term stable disease |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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desmoid tumor