View Clinical Trial (Medical Research Study)
Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
| City: |
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Hormone Refractory Prostate Cancer |
| Purpose: |
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This investigational study involves treatment with an Ad/PSA vaccine for men with prostate
cancer who present with evidence of hormone refractory metastatic disease.
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| Study Summary: |
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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.
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| Criteria: |
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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 bilirubin <1.5
mg/dl.
- 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.
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| NCT ID: |
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NCT00583024 |
| Primary Contact: |
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Principal Investigator
David M Lubaroff, PhD
University of Iowa
David M Lubaroff, PhD
Phone: 319-335-8423
Email: david-lubaroff@uiowa.edu
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| Backup Contact: |
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Email: pamela-zehr@uiowa.edu
Pamela Zehr, RN
Phone: 319-353-8914
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| Location Contact: |
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Iowa City, Iowa 52242
United States
David M Lubaroff, PhD
Phone: 319-335-8423
Email: david-lubaroff@uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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