Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Arm A
Experimental
Not Provided
Intervention(s)
Adenovirus/PSA Vaccine,
Patient eligibility
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.
- Men with a negative bone 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 /= 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.
- Castrate levels of testosterone of
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
