title: Evaluation of phase I/II clinical trials in prostate cancer with dendritic cells and PSMA peptides.
abstract: 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.
authors.affiliation: Cancer Research Division, Pacific Northwest Cancer Foundation, Northwest Hospital, Seattle, Washington 98125, USA.
authors.forename: B A
authors.initials: BA
authors.lastname: Tjoa
authors.forename: S J
authors.initials: SJ
authors.lastname: Simmons
authors.forename: V A
authors.initials: VA
authors.lastname: Bowes
authors.forename: H
authors.initials: H
authors.lastname: Ragde
authors.forename: M
authors.initials: M
authors.lastname: Rogers
authors.forename: A
authors.initials: A
authors.lastname: Elgamal
authors.forename: G M
authors.initials: GM
authors.lastname: Kenny
authors.forename: O E
authors.initials: OE
authors.lastname: Cobb
authors.forename: R C
authors.initials: RC
authors.lastname: Ireton
authors.forename: M J
authors.initials: MJ
authors.lastname: Troychak
authors.forename: M L
authors.initials: ML
authors.lastname: Salgaller
authors.forename: A L
authors.initials: AL
authors.lastname: Boynton
authors.forename: G P
authors.initials: GP
authors.lastname: Murphy
mesh_terms: D000469:Alkaline Phosphatase / Q000378:metabolism; D000951:Antigens, Neoplasm / Q000627:therapeutic use*; D000954:Antigens, Surface; D014408:Biomarkers, Tumor; D002268:Carboxypeptidases / Q000627:therapeutic use*; D002478:Cells, Cultured; D003713:Dendritic Cells / Q000637:transplantation*; D005069:Evaluation Studies as Topic; D043425:Glutamate Carboxypeptidase II; D006801:Humans; D008297:Male; D008991:Monitoring, Physiologic; D011471:Prostatic Neoplasms / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D000951:Antigens, Neoplasm; D000954:Antigens, Surface; D014408:Biomarkers, Tumor; D000469:Alkaline Phosphatase; D002268:Carboxypeptidases; C473848:FOLH1 protein, human; D043425:Glutamate Carboxypeptidase II