Status:
COMPLETED
A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
Lead Sponsor:
Bavarian Nordic
Conditions:
Androgen-insensitive Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief Summary
BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being treated with ...
Detailed Description
MVA-BN®-PRO is a candidate prostate cancer immunotherapy product comprised of a highly attenuated non-replicating vaccinia virus, MVA-BN®, engineered to encode prostate specific antigen (PSA) and pros...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Men, 18 - 75 years of age
- Documented prostate cancer with a rising PSA post androgen suppression or blockade therapy
- Chemotherapy naïve
- ECOG Performance Score of 0,1, or 2
- Life expectancy ≥ 1 year
- No significant cardiac, bone marrow, hepatic, or renal dysfunction; or coagulopathy (defined as no AE ≥ Grade 3 according to NCI CTCAE v 3.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter may be eligible for inclusion provided an exemption is granted by the study Medical Monitor prior to enrollment.
- A negative virology screen for HIV, hepatitis B surface antigen, and hepatitis C
Exclusion
- Metastatic disease
- Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
- History of prior malignancies other than prostate cancer within the past 5 years, excluding basal or squamous cell carcinoma of the skin
- Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin or tobramycin
- Chronic administration (defined as 5 or more days of consecutive use) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN®-PRO. Use of inhaled steroids, nasal sprays, eye drops and topical creams for small body areas is allowed.
- History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement hormones are not excluded.
- Prior solid organ or hematopoietic allogenic transplant(s)
- Receipt of an investigational agent within 28 days of the first planned dose of MVA-BN®-PRO
- Prior "vaccine" therapy for prostate cancer at any time
- Vaccination: Live (attenuated) vaccine (e.g., FluMist®). Vaccination with a live vaccine within 28 days of the first planned dose of MVA-BN®-PRO, or plans to receive a live vaccine within 28 days after the last dose of MVA-BN®-PRO is not allowed
- Vaccination: Killed (inactivated) vaccine (e.g., PneumoVax®). Vaccination with a killed vaccine within 14 days of the first planned dose of MVA-BN®-PRO, or plans to receive a killed vaccine within 14 days after the last dose of MVA-BN®-PRO is not allowed.
- Radiation therapy within 28 days of the first planned dose of MVA-BN®-PRO or plans for radiation therapy during treatment or re-treatment. Prior to initiating palliative radiation during the (re)treatment phase of the study, the Sponsor's medical monitor or designee must be notified.
- Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
- Study personnel
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00629057
Start Date
March 1 2008
End Date
September 1 2011
Last Update
March 13 2019
Active Locations (7)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
3
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
4
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, United States, 28173