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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Aggressive Fibromatosis, Desmoid Tumor

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Non-progression rate after 6 months of treatment

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Bernd Kasper, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg, Mannheim University Medical Center

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CSTI571BDE70

NCT ID:

NCT01137916

Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Aggressive Fibromatosis
  • Desmoid Tumor
  • Aggression
  • Fibroma
  • Fibromatosis, Aggressive

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