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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00085475

Collaborator

(none)

Enrollment

Locations

2.4

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: imatinib mesylate Procedure: conventional surgery	Phase 2

Detailed Description

OBJECTIVES:

Primary

Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
Determine the progression-free rate at 14 weeks in patients treated with this drug.

Secondary

Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug.
Determine the duration of response in patients treated with this drug.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Progression-free rate at 14 weeks []

Secondary Outcome Measures

Response rate as assessed by RECIST criteria []
Progression-free survival []
Overall survival []
Duration of response []
Toxicity as assessed by CTC 3.0 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jules Bordet	Brussels		Belgium	1000
2	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
3	Institut Bergonie	Bordeaux		France	33076
4	CHU de la Timone	Marseille		France	13385
5	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam		Netherlands	1066 CX
6	Leiden University Medical Center	Leiden		Netherlands	2300 CA
7	Christie Hospital NHS Trust	Manchester	England	United Kingdom	M20 4BX