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Prostate CancerNCT00694551

PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment

A study testing Peptide Vaccine and Poly IC-LC in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive Treatment The… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Peptide Vaccine and Poly IC-LC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesin 2 countries
Study dates
2 Dec 2008to 6 Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

Puerto Rico1 site

  • Ponce School of Medicine

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: 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

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 Antigens (HLA)-A2 (+) Patients With Elevated prostatic specific antigen (PSA) After Initial Definitive Treatment

The purpose of the study is to see if the PSMA/TARP proteins in the vaccine, along with the Hiltonol, can arouse and train the immune system to kill the prostate cancer cells. Prostate cancer is the most common cancer and is the second leading cause of cancer deaths in U.S. males. It is curable when it is confined to the prostate (kept from spreading) using surgery or radiation treatments. In some patients the cancer can come back after these treatments. Treatment options for prostate cancer that comes back include procedures or medications which may have significant risks and side effects. Another plan is being looked at that uses the body's immune system to attack prostate cancer cells. A vaccine has been developed that has proteins found in prostate cancer cells. One of the proteins is called PSMA and the other is called TARP. In addition to these proteins, another substance called Poly IC-LC (Hiltonol) will be added to the vaccine to boost its ability to start the immune system.

Read the 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, 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.
Conditions
Prostate Cancer
Being tested
Peptide Vaccine, Poly IC-LC
Keywords
vaccine, PSMA, TARP, immunology, PSA
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peptide VaccineBiological

    Also called Hiltonol, poly IC-LC, PSMA peptide vaccine, TARP peptide vaccine

    Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment.

  • Poly IC-LCDrug

    Also called Hiltonol, NSC-301463

    Administered subcutaneously, one 2 mg/ml vial,(divided into two equal portions for each injection site).

Study groups in NCT00694551
Study groupRoleWhat they receive
A. Level 100 mcg Peptide VaccineExperimentalPeptide vaccine dose level 100 mcg + Poly IC-LC
Receives: Biological: Peptide Vaccine; Drug: Poly IC-LC
B. Level 300 mcg Peptide VaccineExperimentalPeptide vaccine dose level 300 mcg + Poly IC-LC
Receives: Biological: Peptide Vaccine; Drug: Poly IC-LC
C. Level 1 mg Peptide VaccineExperimentalPeptide vaccine dose level 1 mg + Poly IC-LC
Receives: Biological: Peptide Vaccine; Drug: Poly IC-LC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Related Adverse Events - Grade 3 or Higher

    Number of participants with related Grade 3 or higher adverse events. 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.

    Measured: Up to 48 months

Secondary outcomes (2)

  1. Number of Participants With Prostatic Specific Antigen (PSA) Doubling

    Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy.

    Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy.

    Measured: Up to 48 months

  2. Number of Participants Who Did Not Have PSA Doubling

    Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2008 (estimated)
  2. Study start2 Dec 2008
  3. Primary completion28 Feb 2013
  4. Study completion6 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00694551
Sponsor's protocol ID
MCC-15262
Other IDs
106346, 20-14555-05-01
Status last verified
Oct 2019
First submitted
4 Jun 2008
Last updated
4 Oct 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Peptide Vaccine and Poly IC-LC in people with Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Related Adverse Events - Grade 3 or Higher (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00694551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.

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