PURPOSE: We evaluated safety and activity of talactoferrin, a novel immunomodulatory protein in a phase IB trial of patients with refractory solid tumors. METHODS:Thirty-six patients with metastatic cancer who had progressed on, or were ineligible for, standard chemotherapy received single-agent oral talactoferrin. Following dose-escalation, with no DLTs , patients were randomized to 4.5 or 9 g/day talactoferrin. RESULTS:Talactoferrin was well tolerated with apparent anti-cancer activity, particularly in NSCLC and RCC. One patient had a PR (RECIST) and 17 patients (47%) had stable disease (50% disease control rate). Median PFS in the twelve NSCLC and seven RCC patients was 4.2 and 7.3 months, respectively. There was no apparent difference in anti-tumor activity or adverse events between talactoferrin doses. CONCLUSIONS:Oral talactoferrin was well tolerated. Although evaluated in a small number of patients, talactoferrin appeared to have anti-cancer activity, particularly in NSCLC and RCC and should be evaluated further.
RCT Entities:
PURPOSE: We evaluated safety and activity of talactoferrin, a novel immunomodulatory protein in a phase IB trial of patients with refractory solid tumors. METHODS: Thirty-six patients with metastatic cancer who had progressed on, or were ineligible for, standard chemotherapy received single-agent oral talactoferrin. Following dose-escalation, with no DLTs , patients were randomized to 4.5 or 9 g/day talactoferrin. RESULTS: Talactoferrin was well tolerated with apparent anti-cancer activity, particularly in NSCLC and RCC. One patient had a PR (RECIST) and 17 patients (47%) had stable disease (50% disease control rate). Median PFS in the twelve NSCLC and seven RCCpatients was 4.2 and 7.3 months, respectively. There was no apparent difference in anti-tumor activity or adverse events between talactoferrin doses. CONCLUSIONS: Oral talactoferrin was well tolerated. Although evaluated in a small number of patients, talactoferrin appeared to have anti-cancer activity, particularly in NSCLC and RCC and should be evaluated further.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: William K Decker; Jianxia Qiu; Farhang Farhangfar; Jenny H Hester; Dario C Altieri; Augustine Y Lin Journal: Cancer Lett Date: 2005-07-12 Impact factor: 8.679
Authors: Jeffrey S Wolf; Guoyan Li; Atul Varadhachary; Karel Petrak; Mark Schneyer; Daqing Li; Julina Ongkasuwan; Xiaoyu Zhang; Rodney J Taylor; Scott E Strome; Bert W O'Malley Journal: Clin Cancer Res Date: 2007-03-01 Impact factor: 12.531
Authors: Eric Jonasch; Walter M Stadler; Ronald M Bukowski; Teresa G Hayes; Atul Varadhachary; Rajesh Malik; Robert A Figlin; Sandy Srinivas Journal: Cancer Date: 2008-07-01 Impact factor: 6.860