Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss

Heidelberg University1 site in 1 country39 target enrollmentJune 2010

ConditionsAggressive Fibromatosis Desmoid Tumor

InterventionsImatinib

DrugsImatinib

Overview

Phase: Phase 2
Intervention: Imatinib
Conditions: Aggressive Fibromatosis
Sponsor: Heidelberg University
Enrollment: 39
Locations: 1
Primary Endpoint: Non-progression rate after 6 months of treatment
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

December 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Heidelberg University

Responsible Party

Principal Investigator

Bernd Kasper

PD Dr. med.

Heidelberg University

Eligibility Criteria

Inclusion Criteria

•Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
•Measurable disease according to the RECIST criteria
•Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
•No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
•No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
•Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
•Age \> or = 18 years
•WHO PS \< or = 1
•Effective contraception during study medication
•Signed informed consent form

Exclusion Criteria

•Surgical intervention \< 4 weeks
•Prior therapy with imatinib
•Pregnancy or lactation
•Severe hepatic dysfunction
•Known allergic reaction to imatinib or one of its components
•The following laboratory values: Absolute neutrophil count \< 1.5 x 103/mm3, Platelets \< 100,000/mm3, Serum creatinine \> or = 2.5 mg/dl, SGOT and/or SGPT \> 2.5 x ULN (upper limit of normal), Total bilirubin \> 1.5 x ULN
•Participation in another study (four weeks before and during the study)
•Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix