BACKGROUND: A phase I trial involving @entity1 with @entity263 was conducted to assess the safe administration of dendritic cells (DC) and HLA-A0201-specific @entity27425 ( @entity27425 ) peptides (PSM-P1 or -P2). Thirty-three of the phase I @entity1 were subsequently enrolled in a phase II trial, which involved six infusions of DC pulsed with PSM-P1 and -P2 peptides. METHODS: Clinical monitoring was conducted up to 770 days from the start of the phase I study. Data collected included: complete blood count, bone and total alkaline phosphatase, prostate markers, physical examination, performance status, bone scan, ProstaScint scan, and chest X-ray, as well as assays to monitor cellular immune responses. RESULTS: Nine partial responders were identified in the phase II study based on National @entity263 Project (NPCP) criteria, plus 50% reduction of @entity1486 . Four of the partial responders were also responders in the phase I study, with an average response duration of 225 days. Their combined average total response period was over 370 days. Five other responders were nonresponders in the phase I study. Their average partial response period was 196 days. CONCLUSIONS: The responses observed in the phase I and II clinical trials were significant and of long duration. The partial-responder group included @entity1 who continued to respond from phase I, as well as those who started to respond during the phase II trial.

Evaluation of phase I/II clinical trials in @entity263 with dendritic cells and XXXX peptides.

@entity1 :: ('9606', 'Species') :: ['participants', 'patients'] @entity27425 :: ('2346', 'Gene') :: ['PSMA', 'prostate-specific membrane antigen'] @entity263 :: ('MESH:D011471', 'Disease') :: ['Prostate Cancer', 'advanced prostate cancer'] @entity1486 :: ('354', 'Gene') :: ['prostate-specific antigen']
@entity27425 :: (2346,Gene) :: ['PSMA']
