Phase 2 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 rearrangement i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

Phase 1

• Conditions: Soft tissue sarcomas are a family of malignant diseases originating from mesenchymal cells. Two types of theses sarcomas, dermatofibrosarcoma protuberans (DFSP) and giant cell fibriblastoma(GCF), are rare invasive tumors of the dermis which possess intermediate malignancy, of which surgical removal is presently the sole effective treatment.; MedDRA version: 7.0Level: LLTClassification code 10057070

• Registration Number: EUCTR2004-002538-20-GB
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

? Patients must have histologically proven locally advanced or metastatic DFSP or GCF. In case of metastatic disease, tissue can be taken either from the primary tumor or from the metastasis provided the biopsy can be taken without mutilating surgery.
? Patients must have been evaluated by a multidisciplinary team (medical oncologist, surgical oncologist) before entering in the trial.
? Patients must have DFSP or GCS not amenable to surgery, radiation or combined modality treatment with curative intent. Palliative radiation therapy is permitted provided it will not be given to a target lesion.
? Patients must have measurable disease, as defined in the RECIST criteria (see chapter on Response evaluation).
? Patient’s tumor surroundings must be marked on the skin after the surroundings have been optionally identified by ultrasound. This marking should be done using tatouage technique.
? Patient must have progressive disease documented in the last 3 months.
? Patients must have frozen tumor or paraffin embedded tissue available for
immunohistochemical and molecular analysis and for central review of eligibility.
? Patients must have WHO performance status <=2.
? Patients must be >=18 years.
? Patients have been either not pretreated with chemotherapy or with no more than one line of combination chemotherapy with ifosfamide and doxorubicin or 2 lines of single agent therapy or be relapsing within 6 months after the end of adjuvant chemotherapy.
? The patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to treatment start.
? Patients previously irradiated on the lesion must have progressive disease and irradiation should have been stopped for at least six months.
? No concomitant treatment with other cytostatic agents or tyrosine kinase inhibitors.
? Patient must have adequate liver function as defined by a serum bilirubin = 1.5 x the institutional upper limit of normal (IULN), SGOT or SGPT = 2.5 x the institutional upper limit of normal (or = 5 x the institutional upper limit of normal if hepatic metastases is present) obtained within 14 days prior to first registration.
? Patient must have an adequate renal function as defined by a serum creatinine = 1.5 x the institutional upper limit of normal obtained within 14 days prior to first registration.
? Patient must have absolute neutrophil count (ANC) = 2.0x109/l and a platelet count = 100x109/l obtained within 14 days prior to first registration. Baseline hemoglobin must be = 9 g/dl (this may be achieved by transfusion if needed).
? Patient may not have a severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection, e.g., HIV).
? Patient must not be pregnant or nursing. Women/men of reproductive potential must agree to use an effective contraceptive method throughout the study and for up to 3 months following discontinuation of study drug. Women of reproductive potential must have a negative serum
pregnancy test within 7 days prior to treatment start. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
? No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or an

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified