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

Completed · Phase 2

Conditions studied: Hormone Refractory Prostate Cancer

In brief

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

Key facts

Study ID

NCT00583024

Run by

David M Lubaroff

People needed

32

Starts

2007-12-01

Expected to finish

2023-01-31

Last updated by the study team

2023-04-28

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Holden Comprehensive Cancer Center — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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