Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Unicancer

Status and phase

Completed

Phase 2

Phase 1

Conditions

Desmoid Tumor

Treatments

Drug: imatinib mesylate

Study type

Interventional

Funder types

Other

Identifiers

NCT00287846

CDR0000441039

EU-20515

FRE-FNCLCC-SARCOME-05/0401

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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