Overview

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