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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
imatinib mesylate
conventional surgery
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, adult fibrosarcoma, adult malignant fibrous histiocytoma

Eligibility Criteria

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

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

Sites / Locations

  • Institut Jules Bordet
  • U.Z. Gasthuisberg
  • Institut Bergonie
  • CHU de la Timone
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
  • Leiden University Medical Center
  • Christie Hospital NHS Trust

Outcomes

Primary Outcome Measures

Progression-free rate at 14 weeks

Secondary Outcome Measures

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

Full Information

First Posted
June 10, 2004
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00085475
Brief Title
Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, adult fibrosarcoma, adult malignant fibrous histiocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
Progression-free rate at 14 weeks
Secondary Outcome Measure Information:
Title
Response rate as assessed by RECIST criteria
Title
Progression-free survival
Title
Overall survival
Title
Duration of response
Title
Toxicity as assessed by CTC 3.0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan T. van Oosterom, MD, PhD
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Christie Hospital NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20194851
Citation
Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.
Results Reference
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Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma

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