Clincosm LogoSign in Get a demo

Study to Evaluate Imatinib in Desmoid Tumors

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT01137916
Collaborator
Novartis (Industry)
39
Enrollment
1
Location
1
Arm
78
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: drug

Imatinib 800 mg

Drug: Imatinib
800 mg
Other Names:
  • Glivec

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Non-progression rate after 6 months of treatment [6 months]

    Secondary Outcome Measures

    1. Non-progression rate after 12 and 24 months of treatment [12 and 24 months]

    2. Response rate [12 and 24 months]

    3. Progression-free survival (PFS) and overall survival (OS) [12 and 24 months]

    4. Recording of patient quality of life [12 and 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Heidelberg, Mannheim University Medical Center Mannheim Germany 68167

    Sponsors and Collaborators

    • Heidelberg University
    • Novartis

    Investigators

    • Principal Investigator: Bernd Kasper, PD Dr. med., University of Heidelberg, Mannheim University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bernd Kasper, PD Dr. med., Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01137916
    Other Study ID Numbers:
    • CSTI571BDE70
    First Posted:
    Jun 7, 2010
    Last Update Posted:
    May 3, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Fibromatosis, Aggressive
    Fibroma
    Aggression
    Imatinib Mesylate

    Study Results

    No Results Posted as of May 3, 2017