Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
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
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    imatinib ...
  • Study Participants

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.


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


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 Started
Sep 30
Primary Completion
Feb 28
Study Completion
Jun 30
Last Update
Aug 30

Drug imatinib mesylate

Imatinib Experimental

400 to 800 mg/day for a maximal 12 months study duration.



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


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


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
No Results Posted