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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00287846
Enrollment
40
Registered
2006-02-07
Start date
2004-09-30
Completion date
2010-06-30
Last updated
2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desmoid Tumor

Keywords

desmoid tumor

Brief 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.

Detailed 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.

Interventions

DRUGimatinib mesylate

Sponsors

UNICANCER
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Non-progression rate3 months

Secondary

MeasureTime frame
Toxic effects12 months
Tolerance12 months
Response rate5 years
Non-progression rate12 months
Overall survivalthe time between the inclusion date and the death whathever the cause
Quality of life5 years
Correlation of clinical, biological, and genomic markers with response and long-term stable disease5 years
Progression-free survivalthe time between the inclusion date and the progression date

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026