Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Pr… (NCT00085475) | Clinical Trial Compass
CompletedPhase 2
Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma
Belgium, France, Netherlands17 participantsStarted 2004-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 uncontro…
What they're measuring
1
Progression-free rate at 14 weeks
Trial details
NCT IDNCT00085475
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC