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Pilot Immunotherapy Study of Combination PSMA and TARP Peptide With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Pilot Immunotherapy Study of Combination PSMA and TARP Peptide With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment


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,
TARP) from peripheral blood specimens collected during the periods of time defined as
"before", "during" and "after" vaccination.

2. Study the safety and toxicity of varying doses of polypeptide vaccines:
PSMA27-35-PSMA687-701 (VLAGGFFLLYRHVIYAPSSHNKYA) and TARP13-35
(LQLLKQSSRRLEHTFMFLRNFSL) administered with a fixed dose of Poly IC-LC (2 mg
total/treatment) as adjuvant.

3. Describe the impact of the vaccine on the pattern of PSA change in 2 subsets of
patients: with castrate testosterone; with non-suppressed testosterone level/not on
hormone therapy.

4. Identify if there is a basis for selection of a dose of the PSMA and the TARP
polypeptide vaccines for future phase II development of this vaccination strategy,
considering the dose range tested.


Inclusion Criteria:



- 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:

1. At least 1 year after prostatectomy, definitive prostate radiation, or other
definitive-intent local therapy.

2. No testosterone suppression therapy for at least 6 months.

3. PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.

4. Testosterone level >100 ng/ml, at start ("noncastrate").

- Patients on hormone therapy (stratum "Y") must meet all of these:

1. On treatment with gonadotropin-releasing hormone (GnRH) agonist (or orchiectomy)
at least 6 months.

2. testosterone level <50 ng/ml, at start.

3. 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:

1. White blood count (WBC) over 3,500/micro L.

2. Platelet count over 100,000 micro L.

3. Hemoglobin over 10.0 g/dL.

4. Serum creatinine up to 2.0 mg/dL.

5. Alkaline phosphatase up to 2.5 x upper limit of normal (ULN).

6. 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Related Adverse Events

Outcome Description:

Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.

Outcome Time Frame:

Approximately 24 months

Safety Issue:

Yes

Principal Investigator

Mayer Fishman, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-15262

NCT ID:

NCT00694551

Start Date:

October 2008

Completion Date:

July 2014

Related Keywords:

  • Prostate Cancer
  • vaccine
  • PSMA
  • TARP
  • immunology
  • PSA
  • Prostatic Neoplasms

Name

Location

H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612