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

Prostate. 1998 Jun 15;36(1):39-44. doi: 10.1002/(sici)1097-0045(19980615)36:1<39::aid-pros6>3.0.co;2-6.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alkaline Phosphatase / metabolism
  • Antigens, Neoplasm / therapeutic use*
  • Antigens, Surface*
  • Biomarkers, Tumor
  • Carboxypeptidases / therapeutic use*
  • Cells, Cultured
  • Dendritic Cells / transplantation*
  • Evaluation Studies as Topic
  • Glutamate Carboxypeptidase II
  • Humans
  • Male
  • Monitoring, Physiologic
  • Prostatic Neoplasms / therapy*
  • Treatment Outcome


  • Antigens, Neoplasm
  • Antigens, Surface
  • Biomarkers, Tumor
  • Alkaline Phosphatase
  • Carboxypeptidases
  • FOLH1 protein, human
  • Glutamate Carboxypeptidase II