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| ID | Type | Description | Link |
|---|---|---|---|
| GCC-0430 | |||
| CDR0000428259 | Registry Identifier | PDQ (Physician Data Query) |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA:154-163(155L) peptide vaccine | Biological | Given subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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 metastatic prostate cancer
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
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:
More than 4 weeks since prior radiotherapy
No prior radiotherapy to the prostate
See Disease Characteristics
No other concurrent investigational agents
No other concurrent anticancer therapy
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| Name | Affiliation | Role |
|---|---|---|
| H. Richard Alexander | University of Maryland Greenebaum Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201-1595 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19483644 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C544012 | prostate-specific antigen (154-163) |
| D000096202 | Protein Subunit Vaccines |
| C114843 | incomplete Freund's adjuvant |
| C477385 | montanide ISA 51 |
| ID | Term |
|---|---|
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| incomplete Freund's adjuvant | Biological | Given subcutaneously |
|
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| laboratory biomarker analysis | Other | Correlative studies |
|
| Incidence of adverse events graded according to NCI CTCAE version 3.0 | Up to 4 weeks after completion of study treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D045424 |
| Complex Mixtures |