Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma
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)
NCT00085475CI-TRIAL-00008083completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free rate at 14 weeks
Secondary outcomes (5)
- measure
- Response rate as assessed by RECIST criteria
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Duration of response
- measure
- Toxicity as assessed by CTC 3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRutkowski 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. PMID 20194851