Study to Evaluate Imatinib in Desmoid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bernd Kasper, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01137916
First received: June 2, 2010
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Aggressive Fibromatosis
Desmoid Tumor
Drug: Imatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Non-progression rate after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-progression rate after 12 and 24 months of treatment [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) and overall survival (OS) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Recording of patient quality of life [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imatinib
    800 mg
    Other Name: Glivec
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137916

Locations
Germany
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
  More Information

Additional Information:
No publications provided

Responsible Party: Bernd Kasper, PD Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT01137916     History of Changes
Other Study ID Numbers: CSTI571BDE70
Study First Received: June 2, 2010
Last Updated: March 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Aggression
Fibromatosis, Aggressive
Behavioral Symptoms
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014