Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

Adenocarcinoma of the Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109811
• Other study ID #: NCI-2012-02652
• Secondary ID: GCC-0430CDR00004
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2005
• Last updated: January 22, 2013
• Start date: March 2005

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

Biological:
• PSA:154-163(155L) peptide vaccine
Given subcutaneously
• incomplete Freund's adjuvant
Given subcutaneously

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays	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.	From baseline to 1 week after the last dose of study treatment	No
Secondary	Effect of treatment on serum prostate-specific antigen level	The PSA reduction is defined as is at least 50% fall in the serum PSA level after vaccination. The proportion of patients who showed a reduction in serum PSA will be estimated and corresponding 95% confidence intervals will be calculated.	Up to 4 weeks after completion of study treatment	No
Secondary	Incidence of adverse events graded according to NCI CTCAE version 3.0		Up to 4 weeks after completion of study treatment	Yes