Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
A Phase 2 Study of Prostate Specific Antigen Peptide 3A (PSA: 154-163(155L) ) (NSC # 722932, IND#9787) With Montanide ISA-51(NSC #675756, IND #9787) or Montanide® ISA 51 VG (NSC 737063) Vaccination in Prostate Cancer Recurrent
NCT00109811CI-TRIAL-00009028completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well vaccine therapy works in treating patients with recurrent prostate cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| PSA:154-163(155L) peptide vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients receive PSA peptide vaccine (PSA-3A; PSA: 154-163 \[155L\]) emulsified in Montanide ISA-51 subcutaneously once in weeks 0, 2, 4, 6, 10, 14, and 18 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: PSA:154-163(155L) peptide vaccine
- Biological: incomplete Freund's adjuvant
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
- timeFrame
- From baseline to 1 week after the last dose of study treatment
- description
- A response is defined as at least a 5 fold higher frequency of INF-gamma secreting CD8 T cells after vaccination than before. A patient also will be considered a responder if no specific PSA: 154-163(155L) response was found before vaccination and a specific PSA: 154-163(155L) response is identified after vaccination.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Must have undergone radical prostatectomy ≥ 3 months ago * Prostate-specific antigen (PSA) level ≥ 0.6 ng/mL and rising (after radical prostatectomy) on ≥ 2 measurements separated by ≥ 3 months * HLA-A2-positive peripheral blood mononuclear cells by flow cytometry * No clinical evidence of local recurrence * No palpable induration or mass in prostatic fossa * No metastatic prostate cancer * No osseous metastases by bone scan * Performance status - ECOG 0-1 * Performance status - Karnofsky 70-100% * More than 1 year * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal * Hepatitis B and C negative * Creatinine normal * Creatinine clearance ≥ 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study PSA peptide vaccine or Montanide ISA-51 * No history of systemic autoimmune disease or autoimmune disease requiring anti-inflammatory or immunosuppressive therapy * Patients with history of autoimmune thyroiditis are eligible provided the patient requires only thyroid hormone replacement therapy AND disease has been stable for ≥ 1 year * No known HIV positivity * No ongoing or active infection * No primary or secondary immune deficiency * No psychiatric illness or social situation that would preclude study compliance * No history of other uncontrolled illness * No prior chemotherapy * No prior hormonal therapy * No concurrent systemic or ocular steroid therapy, except for any of the following: * Inhaled steroids for asthma * Limited topical steroids * Replacement doses of cortisone * More than 4 weeks since prior radiotherapy * No prior radiotherapy to the prostate * Prior radiotherapy to the pelvis after radical prostatectomy allowed * See Disease Characteristics * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (1)
- DERIVEDKouiavskaia DV, Berard CA, Datena E, Hussain A, Dawson N, Klyushnenkova EN, Alexander RB. Vaccination with agonist peptide PSA: 154-163 (155L) derived from prostate specific antigen induced CD8 T-cell response to the native peptide PSA: 154-163 but failed to induce the reactivity against tumor targets expressing PSA: a phase 2 study in patients with recurrent prostate cancer. J Immunother. 2009 Jul-Aug;32(6):655-66. doi: 10.1097/CJI.0b013e3181a80e0d. PMID 19483644