Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21 (APP21)

April 26, 2023 updated by: David M Lubaroff

Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy

The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be randomized to Arm A (vaccine only) or Arm B (androgen deprivation therapy plus vaccine). On Arm A, subjects can begin the three vaccinations immediately. On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.

Subjects will be vaccinated three times, each injection administered at 30-day intervals. Based upon our earlier clinical trial, the vaccine is considered safe and should not induce any major side effects. The investigators hope that vaccination with this PSA virus will cause the body to produce immunity to the PSA and that immunity will destroy any cell that produces PSA. Since the only cells left in the body that produce PSA will be the cancer cells, the investigators propose that the vaccination and ensuing anti-PSA immunity will kill the prostate cancer cells. Importantly, this treatment should not cause any major side effects as would treatment with anti-cancer drugs.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Holden Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men with prostate cancer who have received prior local therapy (radical prostatectomy or definitive radiation therapy) and have biochemical (PSA) relapse without evidence of radiographic or clinical metastatic disease.
  • For men who had prior prostatectomy, the surgery must have occurred at least 6 months prior to initiation of treatment.
  • For men who had prior definitive radiation therapy, radiation must have been completed at least 1 year prior to initiation of treatment.
  • Exhibit at least three separate rises in serum PSA, at least one month apart with differences >/= 0.03 ng/ml and a total PSA of >0.2 ng/ml.
  • Have a PSA doubling time of >/= 6 months if the baseline serum PSA was >2 ng/ml.
  • Negative bone scans.
  • Negative CT scans of abdomen and pelvis (no evidence of soft tissue lesions >/= 1 cm).
  • Scans must be obtained within 6 weeks of entry into the trial (initiation of treatment).
  • Written informed consent.
  • Age >/= 18 years.
  • Required laboratory values [obtained within 2 weeks of study entry (initiation of treatment)].
  • Serum creatinine </= 2.0 mg/dL
  • Adequate hematologic function: granulocytes >/= 1800 per mm3, platelets >/= 100,000 per mm3, WBC >/= 3700, and lymphocytes >/= 590.
  • Adequate hepatocellular function: AST <3x upper limit of normal and bilirubin <1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).
  • PSA used as an eligibility criterion must be drawn within 42 days prior to injection number 1 and will be redrawn on Day 1 for use as a baseline value.

Exclusion Criteria:

  • Candidates for salvage radiation therapy unless the patient refuses.
  • Active or unresolved clinically significant infection.
  • Parenteral antibiotics <7 days prior to initiation of treatment.
  • Evidence of prior or current CNS metastases. Specific imaging is not necessary in the absence of signs or symptoms.
  • Co-morbid medical conditions which would result in a life expectancy (participation) of less than 1 year.
  • Patients with compromised immune systems; congenital, acquired, or drug-induced (immunosuppressive agents) will be excluded from the study. Use of prednisone at doses higher than 10 mg daily (or equipotent steroid doses) for more than 7 days within the last 3 months is not allowed.
  • No-pre-existing malignancies that required treatment within the past 5 years except for basal or squamous cell cancers of the skin.
  • Prior systemic therapies for prostate cancer not allowed (hormonal therapy, including but not limited to LHRH agonists, antiandrogens, ketoconazole or chemotherapy - mitoxantrone/taxanes/estramustine, etc.) except when patients stopped hormone therapy two or more years prior to enrollment and currently have normal testosterone levels; patients in Arm B, undergoing androgen depletion therapy during the vaccination will be eligible.
  • Prior participation in any vaccine studies for non-infectious diseases.
  • The inability to understand the language and the clinical protocol.
  • Allergy or religious objection to pork products; Gelfoam is produced from pork.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Androgen deprivation therapy (ADT) + Adenovirus/PSA Vaccine
On Arm B, subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the vaccinations.
Biological: Adenovirus/PSA Vaccine
1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
Experimental: Adenovirus/PSA Vaccine
On Arm A, subjects can begin the three vaccinations immediately.
Biological: Adenovirus/PSA Vaccine
1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
Time Frame: 18 months
Anti-immunologic response is defined as an increase of >200% above pre-immunization levels of anti-PSA T cells as measured by ELISPOT analysis
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
Time Frame: 18 months
To evaluate the increase, decrease, or stable response rates (PSA responses and changes in PSADT) of the Ad/PSA vaccine using a prime-boost immunization strategy. PSADT will be calculated based on the MSKCC online calculator.
18 months
Number of Participants Alive and Deceased Following Treatment
Time Frame: Every 6 months, up to 14 years
To evaluate survival in evaluable patients receiving the Ad/PSA vaccine, as measured by 2-year, 5-year, 10-year, and overall survival (OS)
Every 6 months, up to 14 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David M Lubaroff

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: David M Lubaroff, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2007

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 31, 2007

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201705743
  • 200605706 (Other Identifier: Initial UI IRB ID number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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