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Evaluation of phase I/II clinical trials in prostate cancer with dendritic cells and PSMA peptides

✍ Scribed by 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.

Publisher: John Wiley and Sons
Year: 1998
Tongue: English
Weight: 196 KB
Volume: 36
Category: Article
ISSN: 0270-4137
DOI: 10.1002/(sici)1097-0045(19980615)36:1<39::aid-pros6>3.0.co;2-6

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✦ Synopsis

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.

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