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

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ClinicalTrials.gov Identifier: NCT00583024
Recruitment Status : Unknown
Verified October 2019 by David M Lubaroff, University of Iowa.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2007
Last Update Posted : October 25, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
David M Lubaroff, University of Iowa

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE December 31, 2007
Last Update Posted Date October 25, 2019
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
PSA doubling-time response [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • Serum PSA levels [ Time Frame: 18 months ]
  • Immune response [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Serum PSA levels and Immune response [ Time Frame: 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Official Title  ICMJE Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hormone Refractory Prostate Cancer
Intervention  ICMJE Biological: ADENOVIRUS/PSA VACCINE
1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
Study Arms  ICMJE Experimental: Arm A
Intervention: Biological: ADENOVIRUS/PSA VACCINE
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 21, 2010)
66
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
32
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00583024
Other Study ID Numbers  ICMJE 201705744
PC061667/2
200605710 ( Other Identifier: Initial UI IRB ID # )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David M Lubaroff, University of Iowa
Study Sponsor  ICMJE David M Lubaroff
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: David M Lubaroff, PhD University of Iowa
PRS Account University of Iowa
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP