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
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
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
Secondary
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.
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:
Measurable disease by RECIST criteria
No prior malignancy
PATIENT CHARACTERISTICS:
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
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
Nantes-Saint Herblain, 44805, France