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Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PSA:154-163(155L) peptide vaccine
incomplete Freund's adjuvant
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Greenebaum Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Incidence of adverse events graded according to NCI CTCAE version 3.0

Full Information

First Posted
May 3, 2005
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00109811
Brief Title
Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
PSA:154-163(155L) peptide vaccine
Other Intervention Name(s)
PSA PEP VAC, PSA-3A
Intervention Description
Given subcutaneously
Intervention Type
Biological
Intervention Name(s)
incomplete Freund's adjuvant
Other Intervention Name(s)
IFA, ISA-51, Montanide ISA 51
Intervention Description
Given subcutaneously
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays
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.
Time Frame
From baseline to 1 week after the last dose of study treatment
Secondary Outcome Measure Information:
Title
Effect of treatment on serum prostate-specific antigen level
Description
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.
Time Frame
Up to 4 weeks after completion of study treatment
Title
Incidence of adverse events graded according to NCI CTCAE version 3.0
Time Frame
Up to 4 weeks after completion of study treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Richard Alexander
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19483644
Citation
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.
Results Reference
derived

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Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer

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