Study to Evaluate Imatinib in Desmoid Tumors

Desmoid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137916
• Other study ID #: CSTI571BDE70
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2010
• Last updated: May 2, 2017
• Start date: June 2010
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Fibromatosis
• Desmoid Tumor
• Fibroma

Intervention

Drug:
• Imatinib
800 mg

Locations

Country	Name	City	State
Germany	University of Heidelberg, Mannheim University Medical Center	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-progression rate after 6 months of treatment		6 months
Secondary	Non-progression rate after 12 and 24 months of treatment		12 and 24 months
Secondary	Response rate		12 and 24 months
Secondary	Progression-free survival (PFS) and overall survival (OS)		12 and 24 months
Secondary	Recording of patient quality of life		12 and 24 months

External Links

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