Patients with Desmoid Tumor and Chondrosarcoma MedDRA version: 9.1 Level: LLT Classification code 10039491 Term: Sarcoma
Conditions
Interventions
Trade Name: GLIVEC
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
ITALIAN SARCOMA GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological diagnosis of DT and CDS. 2. (a) Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFR-alpha, PDGFR-beta activation and/or presence of PDGF-alpha, or PDGF-beta). This is mandatory. (b) Biomolecular assessment of KIT, PDGFR-alpha, PDGFR-beta activation should be made whenever possible. To this end, if frozen material is not available, obtaining of fresh material is encouraged, if it should be obtained with no major distress for the patient, preferably through an incisional biopsy (to allow immunoprecipitation) or, if this is not feasible, a Trucut biopsy (to allow Western Blot assessment). However, if frozen or fresh material cannot be obtained, paraffined material is also acceptable. The biomolecular assessment will be centralized to the reference centers (to be defined). Mutational analyses is strongly encouraged in any single case. In KIT expressing tumors, mutational analyses is mandatory because GIST data and mastocytosis data clearly show imatinib is not active unless specific exons are involved. (c) Karyotyping is strongly encouraged (preliminary evidences of lower and shorter rate of response in complex karyotype). 3. Measurable or evaluable disease. 4. Surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction, and/or metastatic disease. Debulking surgery before enrolment is allowed. In this case, enrolment should occur at least one month after surgery. 5.(a) DT requires that, at least, radiotherapy (if feasible) and/or endocrine therapy (e.g. tamoxifene) and/or chemotherapy (e.g. methotrexate/vinorelbine) should be considered before enrollment or excluded by physician in charge. (b)CDS requires that proton beam therapy be excluded by physician. 6. Performance status 0, 1, 2 or 3 (ECOG) (see § 7). 7. Adequate end organ function, defined as the following: total bilirubin 1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level. 9. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug. 10. Written, voluntary, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing. 2. Other primary malignancy with /=25% of the bone marrow or within the previous 2 months on target lesion. 9. Major surgery within 2 weeks prior to study entry. 10. Expected non-compliance to medical regimens (e.g. psychiatric diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of Imatinib mesylate 800 mg/day in the treatment of DT and CDS (unresectable, unresectable in a radical fashion, resectable only through demolitive or risk-carrying surgery and/or radiation therapy, metastatic). DT need to have failed standard therapy, e.g. tamoxifen;Secondary Objective: 1. Tumor response according to Choi Criteria. 2. Conversion rate to surgical resectability or non-demolitive surgical resectability. 3. Overall survival (OS), Progression-free survival (PFS). 4. Evaluation and comparison of tumor response by different imaging techniques. 5. Clinical Benefit: this endpoint will be evaluated according to SARC-CTOS method (see section 7.2) and according to modification in Pain and Analgesic scales.;Primary end point(s): Overall response rate | — |
Countries
Italy
Outcome results
None listed