Open-label trial of Imatinib in patients with Desmoid Tumor and Chondrosarcoma - Basket 1

• Conditions: Patients with Desmoid Tumor and Chondrosarcoma; MedDRA version: 9.1Level: LLTClassification code 10039491Term: Sarcoma

• Registration Number: EUCTR2006-006446-33-IT
• Lead Sponsor: ITALIAN SARCOMA GROUP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 ULN, SGOT and SGPT <2.5 x UNL (or <5 x ULN if hepatic metastases are present), creatinine <1.5 x ULN. 8. Adequate bone marrow function, defined as the following: ANC >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

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 <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse. 3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study) 4. Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection). 5. Known brain metastasis. 6. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). 7. Known diagnosis of human immunodeficiency virus (HIV) infection. 8. Previous radiotherapy to >/=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).

Study & Design

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