Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

NCT ID: NCT00109811

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31

Brief Summary

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

Detailed 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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

PSA:154-163(155L) peptide vaccine

Intervention Type: BIOLOGICAL

Given subcutaneously

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

Given subcutaneously

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

PSA:154-163(155L) peptide vaccine

Given subcutaneously

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Given subcutaneously

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

PSA PEP VAC; PSA-3A; IFA; ISA-51; Montanide ISA 51

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H. Richard Alexander

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Locations

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Countries

United States

References

Kouiavskaia 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.

Reference Type: DERIVED

PMID: 19483644 (View on PubMed)

Other Identifiers

GCC-0430

Identifier Type: -

Identifier Source: secondary_id

CDR0000428259

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02652

Identifier Type: -

Identifier Source: org_study_id