A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer

Completed · Phase 1

Conditions studied: Androgen-insensitive Prostate Cancer

In brief

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 androgen suppression therapy or complete androgen blockade. The trial will consist of a treatment with up to 6 vaccinations with MVA-BN®-PRO at monthly intervals, followed by a 1-year follow-up phase. A vaccination may be 1, 2, or 4 injections of study vaccine. The study is designed to examine safety as well as the effect of three different doses on immune response.

Key facts

Study ID

NCT00629057

Run by

Bavarian Nordic

People needed

24

Starts

2008-03-01

Expected to finish

2011-09-01

Last updated by the study team

2019-03-13

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Lawrenceville Urology — Lawrenceville, New Jersey, United States
• Presbyterian Hospital Center for Cancer Research — Charlotte, North Carolina, United States
• Urology Associates — Nashville, Tennessee, United States
• Urology Clinics of North Texas, PA — Dallas, Texas, United States
• Urology Associates of South Texas — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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