Study to Evaluate Imatinib in Desmoid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aggressive Fibromatosis Desmoid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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drug

Imatinib 800 mg

Group Type EXPERIMENTAL

Imatinib

Intervention Type DRUG

800 mg

Interventions

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Imatinib

800 mg

Intervention Type DRUG

Other Intervention Names

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Glivec

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No