Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085475

Purpose

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	Intervention	Phase
Sarcoma	Drug: imatinib mesylate Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free rate at 14 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]
Toxicity as assessed by CTC 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	44
Study Start Date:	April 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085475

Locations

Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
CHU de la Timone
Marseille, France, 13385
Institut Bergonie
Bordeaux, France, 33076
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
United Kingdom, England
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Allan T. van Oosterom, MD, PhD

U.Z. Gasthuisberg

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000370799, EORTC-62027, EUDRACT-2004-002538-20
Study First Received:	June 10, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00085475 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
adult fibrosarcoma
adult malignant fibrous histiocytoma

Additional relevant MeSH terms:

Fibrosarcoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Dermatofibrosarcoma
Protein Kinase Inhibitors
Pharmacologic Actions

Imatinib
Neoplasms, Connective and Soft Tissue
Neoplasms
Therapeutic Uses
Sarcoma
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue

ClinicalTrials.gov processed this record on February 08, 2010