Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-62027 | |||
| EUDRACT-2004-002538-20 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate | Drug | |||
| conventional surgery | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free rate at 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate as assessed by RECIST criteria | ||
| Progression-free survival | ||
| Overall survival |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma
Measurable disease
Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
Documented progressive disease within the past 3 months
Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
At least 6 months since prior radiotherapy
No concurrent radiotherapy
Surgery
Other
More than 28 days since prior investigational drugs
No concurrent therapeutic anticoagulation therapy with warfarin
No other concurrent anticancer agents
No other concurrent investigational drugs
No other concurrent cytostatic agents
No other concurrent tyrosine kinase inhibitors
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Allan T. van Oosterom, MD, PhD | University Hospital, Gasthuisberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | 1000 | Belgium | |||
| U.Z. Gasthuisberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20194851 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of response |
| Toxicity as assessed by CTC 3.0 |
| Leuven |
| B-3000 |
| Belgium |
| Institut Bergonie | Bordeaux | 33076 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 CX | Netherlands |
| Leiden University Medical Center | Leiden | 2300 CA | Netherlands |
| Christie Hospital NHS Trust | Manchester | England | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D005354 | Fibrosarcoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D051642 | Histiocytoma |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided