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Evaluation of phase I/II clinical trials in prostate cancer with dendritic cells and PSMA peptides
Author(s) -
Tjoa B.A.,
Simmons S.J.,
Bowes V.A.,
Ragde H.,
Rogers M.,
Elgamal A.,
Kenny G.M.,
Cobb O.E.,
Ireton R.C.,
Troychak M.J.,
Salgaller M.L.,
Boynton A.L.,
Murphy G.P.
Publication year - 1998
Publication title -
the prostate
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.295
H-Index - 123
eISSN - 1097-0045
pISSN - 0270-4137
DOI - 10.1002/(sici)1097-0045(19980615)36:1<39::aid-pros6>3.0.co;2-6
Subject(s) - prostate cancer , medicine , prostate , immune system , prostate specific antigen , oncology , clinical trial , phases of clinical research , urology , cancer , immunology
BACKGROUND A phase I trial involving patients with advanced prostate cancer was conducted to assess the safe administration of dendritic cells (DC) and HLA‐A0201‐specific prostate‐specific membrane antigen (PSMA) peptides (PSM‐P1 or ‐P2). Thirty‐three of the phase I participants 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 Prostate Cancer Project (NPCP) criteria, plus 50% reduction of prostate‐specific antigen. 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 patients who continued to respond from phase I, as well as those who started to respond during the phase II trial. Prostate 36:39–44, 1998. © 1998 Wiley‐Liss, Inc.