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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: 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