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
18 Years
N/A
Male
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
Trial Information
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
PRIMARY OBJECTIVES:
I. Determine the T-lymphocyte immune response in patients with recurrent adenocarcinoma of
the prostate treated with prostate-specific antigen (PSA) peptide vaccine (PSA-3A; PSA:
154-163 [155L]) emulsified in Montanide ISA-51.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this vaccine in these patients. II. Determine the effect of
this vaccine on serum PSA level in these patients.
OUTLINE: This is a pilot study.
Patients receive prostate-specific antigen (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.
NOTE: *A rise in PSA alone is not considered disease progression.
After completion of study treatment, patients are followed at 1 and 4 weeks.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
Outcome 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.
Outcome Time Frame:
From baseline to 1 week after the last dose of study treatment
Safety Issue:
No
Principal Investigator
H. Richard Alexander
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Maryland Greenebaum Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02652
NCT ID:
NCT00109811
Start Date:
March 2005
Completion Date:
Related Keywords:
- Adenocarcinoma of the Prostate
- Recurrent Prostate Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
