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

Phase 2

Completed

Conditions: Hormone Refractory Prostate Cancer

Interventions: Biological: ADENOVIRUS/PSA VACCINE

Registration Number: NCT00583024

Lead Sponsor: David M Lubaroff

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adenovirus/PSA Vaccine	ADENOVIRUS/PSA VACCINE	Participants will receive three injections of 0.16 ml. (0.125 ml. vaccine + 0.035 ml. Gelfoam) of the Ad/PSA subcutaneously

Primary Outcome Measures

Name	Time	Method
Number of Participants With Stable, Decreased, or Increased PSA Doubling Times (PSADT)	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.
Number of Participants Who Develop a Strong or Modest Anti-PSA Immune Response	18 months	Strong or modest antibody responses to PSA measured by the binding to PSA-secreting cell lines

Secondary Outcome Measures

Name	Time	Method
Number of Participants Alive and Deceased Following Treatment	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)