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Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer (APP22)

Primary Purpose

Hormone Refractory Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADENOVIRUS/PSA VACCINE
Sponsored by
David M Lubaroff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Refractory Prostate Cancer focused on measuring prostate cancer, vaccine, immunotherapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria:

  • Men with prostate cancer who present with evidence of hormone refractory disease (D3).
  • Men with a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes >1 cm), a PSA doubling time of >/= 6 months, and a total PSA of <10 ng/ml, and asymptomatic OR men with a negative bone scan and a negative CT scan with any PSA doubling time and asymptomatic.
  • Scans must be obtained within 6 weeks of initiation of treatment.
  • Written informed consent.
  • Age >/= 18 years.
  • Required laboratory values (obtained within 2 weeks of 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 total bilirubin <1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).
  • Castrate levels of testosterone of </= 50 ng/ml.
  • PSA can be used as an eligibility criterion must be drawn within 28 days prior to injection number 1 and will be drawn on Day 1 for use as a baseline value.

Exclusion criteria:

  • 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 3 months of initiation of treatment is not allowed.
  • Pre-existing malignancies that required treatment within the past 5 years except for basal or squamous cell cancers of the skin.
  • Prior participation in any vaccine studies for non-infectious diseases.
  • Prior chemotherapy, defined as prior cytotoxic chemotherapy for prostate cancer (or any cancer unless more than 5 years have elapsed). Examples of cytotoxic chemotherapy are mitoxantrone/prednisone and taxanes. Drugs such as Casodex or ketoconazole treatment must have been completed at least 6 weeks prior to initiation of treatment.
  • The inability to understand the language and the clinical protocol.
  • Allergy or religious objection to pork products; Gelfoam is produced from pork.

Sites / Locations

  • Holden Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adenovirus/PSA Vaccine

Arm Description

Participants will receive three injections of 0.16 ml. (0.125 ml. vaccine + 0.035 ml. Gelfoam) of the Ad/PSA subcutaneously

Outcomes

Primary Outcome Measures

Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
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.
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
Strong or modest antibody responses to PSA measured by the binding to PSA-secreting cell lines

Secondary Outcome Measures

Number of Participants Alive and Deceased Following Treatment
To evaluate survival in evaluable patients receiving the Ad/PSA vaccine, as measured by 2-year, 5-year, 10-year, and overall survival (OS)

Full Information

First Posted
December 20, 2007
Last Updated
April 26, 2023
Sponsor
David M Lubaroff
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT00583024
Brief Title
Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Acronym
APP22
Official Title
Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2007 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David M Lubaroff
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This investigational study involves treatment with an Ad/PSA vaccine for men with prostate cancer who present with evidence of hormone refractory metastatic disease.
Detailed Description
Subjects in this trial will be eligible if they have recent evidence of hormone refractory disease (D3) and either (a) have a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes >1 cm), with a PSA doubling time of >/= 12 months, a total PSA of < 5 mg/ml, and are asymptomatic; or (b) have a negative bone scan with any PSA doubling time, are asymptomatic, and are not a candidate for chemotherapy. This is a virus vaccine in which the gene for prostate specific antigen (PSA) has been placed into a common cold virus termed adenovirus (Ad) to produce this Ad/PSA product. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Refractory Prostate Cancer
Keywords
prostate cancer, vaccine, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adenovirus/PSA Vaccine
Arm Type
Experimental
Arm Description
Participants will receive three injections of 0.16 ml. (0.125 ml. vaccine + 0.035 ml. Gelfoam) of the Ad/PSA subcutaneously
Intervention Type
Biological
Intervention Name(s)
ADENOVIRUS/PSA VACCINE
Intervention Description
1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
Primary Outcome Measure Information:
Title
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)
Description
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.
Time Frame
18 months
Title
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response
Description
Strong or modest antibody responses to PSA measured by the binding to PSA-secreting cell lines
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of Participants Alive and Deceased Following Treatment
Description
To evaluate survival in evaluable patients receiving the Ad/PSA vaccine, as measured by 2-year, 5-year, 10-year, and overall survival (OS)
Time Frame
Every 6 months, up to 14 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Men with prostate cancer who present with evidence of hormone refractory disease (D3). Men with a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes >1 cm), a PSA doubling time of >/= 6 months, and a total PSA of <10 ng/ml, and asymptomatic OR men with a negative bone scan and a negative CT scan with any PSA doubling time and asymptomatic. Scans must be obtained within 6 weeks of initiation of treatment. Written informed consent. Age >/= 18 years. Required laboratory values (obtained within 2 weeks of 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 total bilirubin <1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome). Castrate levels of testosterone of </= 50 ng/ml. PSA can be used as an eligibility criterion must be drawn within 28 days prior to injection number 1 and will be drawn on Day 1 for use as a baseline value. Exclusion criteria: 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 3 months of initiation of treatment is not allowed. Pre-existing malignancies that required treatment within the past 5 years except for basal or squamous cell cancers of the skin. Prior participation in any vaccine studies for non-infectious diseases. Prior chemotherapy, defined as prior cytotoxic chemotherapy for prostate cancer (or any cancer unless more than 5 years have elapsed). Examples of cytotoxic chemotherapy are mitoxantrone/prednisone and taxanes. Drugs such as Casodex or ketoconazole treatment must have been completed at least 6 weeks prior to initiation of treatment. The inability to understand the language and the clinical protocol. Allergy or religious objection to pork products; Gelfoam is produced from pork.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Lubaroff, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11745487
Citation
Elzey BD, Siemens DR, Ratliff TL, Lubaroff DM. Immunization with type 5 adenovirus recombinant for a tumor antigen in combination with recombinant canarypox virus (ALVAC) cytokine gene delivery induces destruction of established prostate tumors. Int J Cancer. 2001 Dec 15;94(6):842-9. doi: 10.1002/ijc.1556.
Results Reference
background
PubMed Identifier
16454655
Citation
Lubaroff DM, Konety B, Link BK, Ratliff TL, Madsen T, Shannon M, Ecklund D, Williams RD. Clinical protocol: phase I study of an adenovirus/prostate-specific antigen vaccine in men with metastatic prostate cancer. Hum Gene Ther. 2006 Feb;17(2):220-9. doi: 10.1089/hum.2006.17.220. No abstract available.
Results Reference
background
PubMed Identifier
11839651
Citation
Cavacini LA, Duval M, Eder JP, Posner MR. Evidence of determinant spreading in the antibody responses to prostate cell surface antigens in patients immunized with prostate-specific antigen. Clin Cancer Res. 2002 Feb;8(2):368-73.
Results Reference
result

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Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer

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