Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Phase 1

Completed

• Conditions: Desmoid Tumor
• Interventions: Drug: imatinib mesylate

• Registration Number: NCT00287846
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-02
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Study Completion: 2010-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib	imatinib mesylate	400 to 800 mg/day for a maximal 12 months study duration.

Primary Outcome Measures

Name	Time	Method
Non-progression rate	3 months

Secondary Outcome Measures

Name	Time	Method
Non-progression rate	12 months
Response rate	5 years
Overall survival	the time between the inclusion date and the death whathever the cause
Quality of life	5 years
Correlation of clinical, biological, and genomic markers with response and long-term stable disease	5 years
Toxic effects	12 months
Tolerance	12 months
Progression-free survival	the time between the inclusion date and the progression date

Trial Locations

Locations (23)

Centre Eugene Marquis; 🇫🇷 Rennes, France

Hopital Foch; 🇫🇷 Suresnes, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Hopital Edouard Herriot - Lyon; 🇫🇷 Lyon, France

Institut Curie Hopital; 🇫🇷 Paris, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut Jean Godinot; 🇫🇷 Reims, France

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

CHU de la Timone; 🇫🇷 Marseille, France

Hopital Tenon; 🇫🇷 Paris, France

Hopitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France