Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Treatments: Biological: PSA:154-163(155L) peptide vaccine; Biological: incomplete Freund's adjuvant; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: NIH

Identifiers

NCT00109811

CDR0000428259 (Registry Identifier)

GCC-0430

NCI-2012-02652

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Treatment

Experimental group

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.

Treatment:

Biological: incomplete Freund's adjuvant

Biological: PSA:154-163(155L) peptide vaccine

Other: laboratory biomarker analysis