Vaccine Therapy in Treating Patients With Recurrent Prostate Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00109811
First received: May 3, 2005
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Prostate Recurrent Prostate Cancer |
Biological: PSA:154-163(155L) peptide vaccine Biological: incomplete Freund's adjuvant Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Change in frequency of CD8 T-lymphocyte precursors in peripheral blood mononuclear cells (PBMC), measured by ELISPOT assays [ Time Frame: From baseline to 1 week after the last dose of study treatment ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 32 |
| Study Start Date: | March 2005 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Biological: PSA:154-163(155L) peptide vaccine
Given subcutaneously
Other Names:
Biological: incomplete Freund's adjuvant
Given subcutaneously
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109811
Locations
| United States, Maryland | |
| University of Maryland Greenebaum Cancer Center | |
| Baltimore, Maryland, United States, 21201-1595 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | H. Richard Alexander | University of Maryland Greenebaum Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00109811 History of Changes |
| Other Study ID Numbers: | NCI-2012-02652, GCC-0430, CDR0000428259 |
| Study First Received: | May 3, 2005 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Freund's Adjuvant Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013