Clinical trial · Interventional
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
NCT00287846CI-TRIAL-00023702completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Desmoid Tumor | Desmoid Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib
- description
- 400 to 800 mg/day for a maximal 12 months study duration.
- interventionNames
- Drug: imatinib mesylate
Primary outcomes (1)
- measure
- Non-progression rate
- timeFrame
- 3 months
Secondary outcomes (8)
- measure
- Non-progression rate
- timeFrame
- 12 months
- measure
- Toxic effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTPenel N, Le Cesne A, Bui BN, Perol D, Brain EG, Ray-Coquard I, Guillemet C, Chevreau C, Cupissol D, Chabaud S, Jimenez M, Duffaud F, Piperno-Neumann S, Mignot L, Blay JY. Imatinib for progressive and recurrent aggressive fibromatosis (desmoid tumors): an FNCLCC/French Sarcoma Group phase II trial with a long-term follow-up. Ann Oncol. 2011 Feb;22(2):452-7. doi: 10.1093/annonc/mdq341. Epub 2010 Jul 9. PMID 20622000
- RESULTFayette J, Dufresne A, Penel N, et al.: Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival: a FNCLCC French Sarcoma Group-GETO study. [Abstract] J Clin Oncol 25 (Suppl 18): A-10062, 560s, 2007.