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Hormone Refractory Prostate CancerPhase 2APP22NCT00583024

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

A Phase 2 study testing ADENOVIRUS/PSA VACCINE in people with Hormone Refractory Prostate Cancer, run by David M Lubaroff at 1 site in United States.

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

This investigational study involves treatment with an Ad/PSA vaccine for men with prostate cancer who present with evidence of hormone refractory metastatic disease. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
ADENOVIRUS/PSA VACCINE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Dec 2007to 31 Jan 2023
Phase
Phase 2
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 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

Other trials in United States

About this study

This investigational study involves treatment with an Ad/PSA vaccine for men with prostate cancer who present with evidence of hormone refractory metastatic disease.

Read the 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.

Being tested
ADENOVIRUS/PSA VACCINE
Keywords
prostate cancer, vaccine, immunotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ADENOVIRUS/PSA VACCINEBiological

    1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60

Study groups in NCT00583024
Study groupRoleWhat they receive
Adenovirus/PSA VaccineExperimentalParticipants will receive three injections of 0.16 ml. (0.125 ml. vaccine + 0.035 ml. Gelfoam) of the Ad/PSA subcutaneously
Receives: Biological: ADENOVIRUS/PSA VACCINE

What is being measured

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

  1. 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.

    Measured: 18 months

  2. 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

    Measured: 18 months

Secondary outcomes (1)

  1. 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)

    Measured: Every 6 months, up to 14 years

Timeline

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

  1. First posted31 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completion31 Dec 2020
  4. Study completion31 Jan 2023

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00583024
Sponsor's protocol ID
201705744
Other IDs
PC061667/2, 200605710
Acronym
APP22
Status last verified
Apr 2023
First submitted
20 Dec 2007
Last updated
28 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11745487

  • 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.

    PubMed 16454655

  • 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.

    PubMed 11839651

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ADENOVIRUS/PSA VACCINE in people with Hormone Refractory Prostate Cancer, run by David M Lubaroff at 1 site in United States.

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 11 inclusion and 10 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2023). 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?

Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT00583024, which also lists 3 linked publications.

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 28 Apr 2023.

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