Trial record 2 of 23 for:
"desmoid tumor"
Study to Evaluate Imatinib in Desmoid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Heidelberg University
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
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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:
Genetics Home Reference related topics:
desmoid tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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
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 Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms, Fibrous Tissue Imatinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015