Status:
COMPLETED
A Pilot Study of Vaccination With Epitope-Enhanced TARP Peptide and TARP Peptide-Pulsed Dendritic Cells in the Treatment of Stage D0 Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Specific Antigens
Prostate Neoplasms
Eligibility:
MALE
18-100 years
Phase:
PHASE1
Brief Summary
Background: * PSA (prostate specific antigen) is a protein found on normal and cancerous prostate cells. Levels of this protein are used to identify men who are at risk for prostate cancer and to mon...
Detailed Description
BACKGROUND: * T-cell receptor alternate reading frame protein (TARP) is expressed by both normal and malignant prostate cancer tissue and is found in about 95% of prostate cancer specimens. TARP is i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
- Human leukocyte antigen-A (HLA-A)\*201 positive
- Patients must have
- Completed and recovered from all prior definitive therapy (surgery, brachytherapy, cryotherapy or radiotherapy) for the primary tumor, or other definitive-intent local therapy.
- Stage D0 disease with documented biochemical progression documented by a rising prostate-specific antigen (PSA).
- No evidence of metastatic disease by physical examination, computed tomography (CT) scan or bone scan.
- For patients following definitive radiation therapy or cryotherapy: a rise in PSA of \>2ng/mL above the nadir.
- For patients following radical prostatectomy: 2 absolute PSA values \> 0.3 ng/mL
- Non-castrate level of testosterone: greater than or equal to 50 ng/dL (prior androgen deprivation treatment (ADT) allowed; must be greater than or equal to 6 months since last dose of ADT).
- A Pre-Enrollment/Baseline prostate-specific antigen doubling time (PSADT) \> 3 months and less than or equal to 15 months
- Patients must have greater than or equal to 3 PSA measurements over greater than or equal to 3 months
- The interval between PSA measurements must be greater than or equal to 4 weeks
- For patients receiving 5-alpha reductase inhibitors (5ARI) e.g. finasteride or dutasteride, only PSA values obtained after at least 3 months on therapy may be used to calculate PSADT.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky 70-100%
- Life expectancy greater than or equal to 1 year.
- Hemoglobin greater than or equal to 10.0 gm/dL, white blood cell (WBC) greater than or equal to 2,500/mm(3), absolute lymphocyte count (ALC) greater than or equal to 500/mm(3), absolute neutrophil count (ANC) greater than or equal to 1,000/mm(3), platelet count greater than or equal to 100,000/mm(3).
- Prothrombin time (PT)/ partial thromboplastin time (PTT) less than or equal to 1.5 times upper limits of normal (ULN) unless receiving clinically indicated anticoagulant therapy.
- Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) \< 2.5 times ULN, total bilirubin \< 1.5 times ULN, creatinine (Cr) \< 1.5 times ULN, estimated glomerular filtration rate (GFR) estimated glomerular filtration rate (eGFR) \> 60 ml/min.
- Hepatitis B and C negative, unless the result is consistent with prior vaccination or prior infection with full recovery.
- Human immunodeficiency virus (HIV) negative
- No use of investigational agents within 4 weeks of study enrollment.
- No use of immunosuppressive (cytotoxic chemotherapy, systemic steroids) or immunomodulating agents (including intravenous immune globulin (IVIG) within 8 weeks of study entry. Note: topical and intranasal steroid therapy is permitted.
- No other concurrent anticancer therapy.
- No alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto). Note: patients receiving medications for urinary symptoms such as Flomax or 5-alpha reductase inhibitors (finasteride and dutasteride) on a chronic stable dose for at least 3 months are allowed.
- No prior prostate cancer vaccines expressing TARP or HLA A2.
- Able to understand and provide Informed Consent.
- EXCLUSION CRITERIA:
- HLA-A\*201 negative
- Patients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skin, or superficial bladder carcinoma.
- Patients with active infection.
- Patients with brain, visceral or bony metastatic disease.
- Patients in who live attenuated intranasal influenza vaccine (FluMist) is contraindicated including individuals with asthma or reactive airways disease, cardiovascular or pulmonary disease, chronic metabolic diseases (including diabetes mellitus), renal dysfunction or hemoglobinopathies.
Exclusion
Key Trial Info
Start Date :
May 11 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00972309
Start Date
May 11 2009
End Date
February 4 2015
Last Update
October 12 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892