Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
  • Determine the progression-free rate at 14 weeks in patients treated with this drug.

Secondary

  • Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug.
  • Determine the duration of response in patients treated with this drug.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Marseille, France, 13385
        • CHU de la Timone
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
  • United Kingdom
    • England
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma

    • Locally advanced or metastatic disease
  • Measurable disease
  • Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent

  • Documented progressive disease within the past 3 months

    • Previously irradiated lesions must show disease progression

  • Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization

    • Translocation t(17;22)(q22;q13)
  • No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL* NOTE: *Transfusion allowed

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin ≤ 1.5 times ULN
  • No uncontrolled hepatic disease

Renal

  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled renal disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No uncontrolled diabetes
  • No active or uncontrolled infection
  • No concurrent severe or uncontrolled medical disease
  • No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent anticancer biologic agents

Chemotherapy

  • See Disease Characteristics
  • More than 28 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy

  • No concurrent radiotherapy

    • Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion

Surgery

  • Not specified

Other

  • More than 28 days since prior investigational drugs

  • No concurrent therapeutic anticoagulation therapy with warfarin

    • Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
  • No other concurrent cytostatic agents
  • No other concurrent tyrosine kinase inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free rate at 14 weeks

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Duration of response
Response rate as assessed by RECIST criteria
Toxicity as assessed by CTC 3.0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Allan T. van Oosterom, MD, PhD, University Hospital, Gasthuisberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

June 10, 2004

First Submitted That Met QC Criteria

June 10, 2004

First Posted (Estimate)

June 11, 2004

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-62027
  • EUDRACT-2004-002538-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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