Overview
Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTCTreatments:
Imatinib Mesylate
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