Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Imatinib Mesylate

Criteria

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