Radioimmunotherapy With 131I-L19SIP in Patients With Cancer
|ClinicalTrials.gov Identifier: NCT01242943|
Recruitment Status : Terminated (With the determination of the RD and a well established understanding of the safety and tolerability profile, the main endpoints of the study have been met.)
First Posted : November 17, 2010
Last Update Posted : November 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Patients With Cancer||Drug: 131I-L19SIP Radioimmunotherapy (RIT)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||May 2011|
Experimental: L19SIP I131
Phase I: Multicentre, open-label, two-step single-arm dose escalation study in sequential cohorts of patients with cancer.
Phase II: Prospective, open-label, single-arm, multicentre study of 131I-L19SIP, given at the RD as determined in phase I.
Drug: 131I-L19SIP Radioimmunotherapy (RIT)
Dosimetric evaluation with 131I-L19SIP will be performed to assess eligibility for Radioimmunotherapy.
Phase I: Patients eligible for Radioimmunotherapy will receive escalating doses of therapeutic 131I-L19SIP administration (intravenously) at the following dosages (expressed in mCi/m2): 111, 139 and 167.
- Phase I: Maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]Establishment of the maximum tolerated dose (MTD) and the recommended dose (RD) for the radiolabelled L19SIP monoclonal antibody.
- Phase II: Antitumour activity [ Time Frame: 1- 14 months ]Investigation of the antitumour activity of 131I-L19SIP at the RD, in patients with advanced cancer.
- Phase I: Study of the variation of radioactivity of 131I in whole blood, at several time intervals (Pharmacokinetics) [ Time Frame: 2 days ]Evaluation of the pharmacokinetics of 131IL19SIP.
- Phase II: Safety profile [ Time Frame: 30 days/ administration ]Determination of the overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and following cycles in all patients receiving a therapeutic dose.
- Phase II: Overall Response Rate (ORR) [ Time Frame: 6 and 12 months ]Evaluation of the overall Response Rate (ORR) for all patients having received a therapeutic dose.
- Phase II: Progression free survival (PFS) [ Time Frame: 6 and 12 months ]Evaluation of the progression free survival (PFS) for all patients having received a therapeutic dose.
- Phase II: Survival rate [ Time Frame: 6 and 12 months ]Evaluation of the survival rate at 6 and 12 months and overall survival time for all patients having received a therapeutic dose.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242943
|University Hospital Pisa|
|Pisa, Tuscany, Italy, 56126|
|Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc)|
|Irccs Ospedale Casa Sollievo Della Sofferenza - San Giovanni Rotondo|
|San Giovanni Rotondo (FG), Italy|
|University College London, UCL Cancer Institute|
|London, United Kingdom|
|Principal Investigator:||Giuliano Mariani, Prof||University Hospital Pisa, Italy|
|Principal Investigator:||Tim Meyer, Dr||University College London (UCL) Cancer Institute|