A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
BNIT-PR-001
An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
1 other identifier
interventional
24
1 country
7
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMarch 13, 2019
June 1, 2011
2.8 years
February 25, 2008
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of single and multiple injection regimens of MVA-BN®-PRO for the treatment of androgen-insensitive prostate cancer.
Continuous
Secondary Outcomes (1)
To evaluate the ability of MVA-BN®-PRO to generate humoral and cellular immune responses to prostate antigens, and to define an optimal dose for future studies.
Continuous
Study Arms (3)
1
EXPERIMENTALLowest dose level
2
EXPERIMENTALMiddle level dose
3
EXPERIMENTALHighest dose level
Interventions
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bavarian Nordiclead
Study Sites (7)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, 28173, United States
Urology Associates
Nashville, Tennessee, United States
Urology Clinics of North Texas, PA
Dallas, Texas, 75231, United States
Urology Associates of South Texas
McAllen, Texas, 78503, United States
MeSH Terms
Conditions
Interventions
Study Officials
- STUDY DIRECTOR
Olga Bandman
Bavarian Nordic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 5, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2010
Study Completion
September 1, 2011
Last Updated
March 13, 2019
Record last verified: 2011-06