Study to Evaluate Imatinib in Desmoid Tumors

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Aggressive Fibromatosis; Desmoid Tumor

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01137916

CSTI571BDE70

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

drug

Experimental group

Description:

Imatinib 800 mg

Treatment:

Drug: Imatinib