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Study to Evaluate Imatinib in Desmoid Tumors

Primary Purpose

Aggressive Fibromatosis, Desmoid Tumor

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Imatinib
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive Fibromatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Heidelberg, Mannheim University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

drug

Arm Description

Imatinib 800 mg

Outcomes

Primary Outcome Measures

Non-progression rate after 6 months of treatment

Secondary Outcome Measures

Non-progression rate after 12 and 24 months of treatment
Response rate
Progression-free survival (PFS) and overall survival (OS)
Recording of patient quality of life

Full Information

First Posted
June 2, 2010
Last Updated
May 2, 2017
Sponsor
Heidelberg University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01137916
Brief Title
Study to Evaluate Imatinib in Desmoid Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Fibromatosis, Desmoid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug
Arm Type
Experimental
Arm Description
Imatinib 800 mg
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Glivec
Intervention Description
800 mg
Primary Outcome Measure Information:
Title
Non-progression rate after 6 months of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Non-progression rate after 12 and 24 months of treatment
Time Frame
12 and 24 months
Title
Response rate
Time Frame
12 and 24 months
Title
Progression-free survival (PFS) and overall survival (OS)
Time Frame
12 and 24 months
Title
Recording of patient quality of life
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Kasper, PD Dr. med.
Organizational Affiliation
University of Heidelberg, Mannheim University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Heidelberg, Mannheim University Medical Center
City
Mannheim
ZIP/Postal Code
68167
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28282612
Citation
Kasper B, Gruenwald V, Reichardt P, Bauer S, Rauch G, Limprecht R, Sommer M, Dimitrakopoulou-Strauss A, Pilz L, Haller F, Hohenberger P. Imatinib induces sustained progression arrest in RECIST progressive desmoid tumours: Final results of a phase II study of the German Interdisciplinary Sarcoma Group (GISG). Eur J Cancer. 2017 May;76:60-67. doi: 10.1016/j.ejca.2017.02.001. Epub 2017 Mar 8.
Results Reference
derived
PubMed Identifier
26861905
Citation
Kasper B, Gruenwald V, Reichardt P, Bauer S, Hohenberger P, Haller F. Correlation of CTNNB1 Mutation Status with Progression Arrest Rate in RECIST Progressive Desmoid-Type Fibromatosis Treated with Imatinib: Translational Research Results from a Phase 2 Study of the German Interdisciplinary Sarcoma Group (GISG-01). Ann Surg Oncol. 2016 Jun;23(6):1924-7. doi: 10.1245/s10434-016-5132-4. Epub 2016 Feb 9.
Results Reference
derived
Links:
URL
http://www.gisg.de
Description
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Study to Evaluate Imatinib in Desmoid Tumors

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