Status:
COMPLETED
PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Pilot Immunotherapy Study of Combination Prostate Specific Membrane Antigen (PSMA) and T-cell receptor γ alternate reading frame protein (TARP) Peptide With Poly IC-LC Adjuvant in Human Leukocyte Anti...
Detailed Description
Detailed Objectives: 1. Estimate the frequency of immunological efficacy of the vaccine by comparison of the in vitro enzyme-linked immunosorbent spot (ELISpot) test results, for each antigen (PSMA, ...
Eligibility Criteria
Inclusion
- History of histologically confirmed prostate cancer.
- Competence to understand the patient information and provide written informed consent, and willingness and ability to return to H. Lee Moffitt Cancer Center for planned treatments and follow-up.
- Absence of evidence of metastatic disease by current physical exam or by current imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\] pelvis, and bone scan within 60 days of first treatment).
- Patients not on hormone therapy (stratum "N") must meet all of these:
- At least 1 year after prostatectomy, definitive prostate radiation, or other definitive-intent local therapy.
- No testosterone suppression therapy for at least 6 months.
- PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.
- Testosterone level \>100 ng/ml, at start ("noncastrate").
- Patients on hormone therapy (stratum "Y") must meet all of these:
- On treatment with gonadotropin-releasing hormone (GnRH) agonist (or orchiectomy) at least 6 months.
- testosterone level \<50 ng/ml, at start.
- PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.
- Laboratory values obtained 0-14 days prior to start of therapy:
- White blood count (WBC) over 3,500/micro L.
- Platelet count over 100,000 micro L.
- Hemoglobin over 10.0 g/dL.
- Serum creatinine up to 2.0 mg/dL.
- Alkaline phosphatase up to 2.5 x upper limit of normal (ULN).
- Aspartic transaminase (AST) up to 2.5 x ULN.
- Life expectancy at least 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
Exclusion
- Known standard therapy for the patient's disease that is potentially curative.
- A known immunodeficiency including HIV. Appropriate trials for individuals with HIV may be considered at a later date.
- History of other malignancy besides prostate cancer in the last 5 years, except non-melanoma skin cancer treated with local resection only. (The effect of study treatment on other, potentially dormant malignant diseases is not known).
- Use of oral or inhaled or parenteral corticosteroids or of other immunomodulatory drugs within the 60 days of start. \[Use of steroids after start will be considered by the principal investigator (PI) on a case-by-case basis.\]
- Use of estrogens (including herbal phytoestrogens) or ketoconazole within 30 days of start, or during the study.
- Failure to fully recover to grade 1 or better from effects of prior chemotherapy regardless of interval since last treatment.
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational agent in last 30 days (one month washout to start of treatment; patients could register but not start until the washout).
- Known hypersensitivity to one or more components of the study medication.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
December 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00694551
Start Date
December 2 2008
End Date
December 6 2018
Last Update
October 4 2019
Active Locations (2)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
Ponce School of Medicine
Ponce, Puerto Rico, 00716