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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

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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 CenterBaltimore, Maryland  21201