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Sponsored by: |
BN ImmunoTherapeutics |
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Information provided by: | BN ImmunoTherapeutics |
ClinicalTrials.gov Identifier: | NCT00629057 |
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.
Condition | Intervention | Phase |
---|---|---|
Androgen-Insensitive Prostate Cancer |
Biological: MVA-BN-PRO |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Lowest dose level
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Biological: MVA-BN-PRO
1x10e8 TCID50 q 4 wks x 6
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2: Experimental
Middle level dose
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Biological: MVA-BN-PRO
2 x 10e8 TCID50 q 4 wks x 6
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3: Experimental
Highest dose level
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Biological: MVA-BN-PRO
4 x 10e8 TCID50 q 4 wks x 6
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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 prostate acid phosphatase (PAP) proteins. The MVA-BN®-based vaccine provides innate and adaptive immune activating factors, and vaccination by this strategy will be evaluated for its capacity to help override self and tumor tolerance mechanisms.
Previous work has shown PSA and PAP antigens to be immunogenic in humans when presented with immune stimulatory components. Multiple clinical studies have demonstrated promising activity of PSA-targeted vaccinia-based immunotherapy. Additionally, PAP-based cellular therapy immunization approaches, have shown promise in Phase III clinical trials and provided for enhanced survival. The strategy undertaken by BNIT is to combine both antigens in the MVA-BN® vector to enhance the immunogenic effect and to help mitigate development of tumor resistance.
This trial examines three vaccination regimens of MVA-BN®-PRO:
Vaccine is provided at (0.5cc/dose/1x10e8 TCID50)
These dose regimens are based on the current dose of MVA-BN® (1x10e8 TCID50 by sc injection) under development as a prophylactic vaccine for the prevention of smallpox, and on related clinical studies of MVA-nef-based vaccines (5x10e8 TCID50) for induction of heterologous immunity.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
Exclusion Criteria:
Contact: Amber Mann | (910) 558-2956 | amber.mann@wilm.ppdi.com |
Contact: Leslie Brand, MS, MBA | 650-681-4657 | leslie.brand@bn-it.com |
United States, Alabama | |
Urology Centers of Alabama | Recruiting |
Homewood, Alabama, United States, 35209 | |
Contact: Judy McMillan, RN 205-445-0125 jmcmillan@urologyal.com | |
Principal Investigator: George W. Adams, MD | |
United States, District of Columbia | |
Walter Reed Army Medical Center | Recruiting |
Washington, District of Columbia, United States, 20307 | |
Contact: Maryellen Colston, RN 202-782-4010 maryellen.colston@na.amedd.army.mil | |
Contact: Mary D. McGarvey, RN 202-782-3948 mary.mcgarvey@na.amedd.army.mil | |
Principal Investigator: David McLeod, MD | |
Sub-Investigator: Stephen M. Brassell, MC, MD | |
Sub-Investigator: Ginger Lew-Zampieri, PA-C | |
Sub-Investigator: Mary McGarvey, RN | |
Sub-Investigator: Raziya Dozier, CCRP | |
Sub-Investigator: Kimberly Peay, MS | |
Sub-Investigator: Judith Travis, RN | |
Sub-Investigator: Maryellen Colston, RN | |
Sub-Investigator: Gary Blake, CCRP | |
United States, New Jersey | |
Lawrenceville Urology | Recruiting |
Lawrenceville, New Jersey, United States, 08648 | |
Contact: David Adamson 609-895-0735 ask@advancemed.info | |
Contact: Julie Prettyman, RN 609-895-0173 jprettyman@advancemed.info | |
Principal Investigator: Gary Karlin, MD | |
Sub-Investigator: Russell M. Freid, MD | |
Sub-Investigator: Jarad S. Fingerman, DO | |
Sub-Investigator: Julie Prettyman, RN | |
United States, North Carolina | |
Presbyterian Hospital Center for Cancer Research | Recruiting |
Charlotte, North Carolina, United States, 28173 | |
Contact: Ruth King 704-384-8920 mking@novanthealth.org | |
Contact: Jayson M Randall, BS 704-384-8920 jmrandall@novanthealth.org | |
Principal Investigator: Richard Reiling, MD | |
United States, Tennessee | |
Urology Associates | Recruiting |
Nashville, Tennessee, United States, 37209 | |
Contact: Rick Trotter 615-250-2968 crtrotter@ua-pc.com | |
Contact: David Bilhartz, MD dlbilhartz@ua-pc.com | |
Principal Investigator: David Bilhartz, MD | |
Sub-Investigator: Raoul Concepcion, MD | |
United States, Texas | |
Urology Clinics of North Texas, PA | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact: Ami Bosley 214-580-1482 bosley@urologyclinics.com | |
Principal Investigator: James Cochran, MD | |
Sub-Investigator: Pat F. Fulgham, MD | |
Sub-Investigator: Chester F. Graham, MD | |
Sub-Investigator: Michael B. Gross, MD | |
Sub-Investigator: Peggy S. Jackson, RN | |
Sub-Investigator: Keith T. Kadesky, MD | |
Sub-Investigator: Meredith L. Lightfoot, MD | |
Sub-Investigator: Homa J. Porter, MD | |
Sub-Investigator: Mathew L. Wilner, MD | |
Urology Associates of South Texas | Recruiting |
McAllen, Texas, United States, 78503 | |
Contact: Marissa Leal 956-429-0357 marissa.leal@uast.net | |
Principal Investigator: Henry Ruiz, MD | |
Sub-Investigator: Carlos P. DeJuana, MD | |
Sub-Investigator: Alexander J. Feigl, MD |
Study Director: | Wayne R Godfrey, MD | BN ImmunoTherapeutics, Inc. |
Responsible Party: | BN ImmunoTherapeutics, Inc. ( Wayne R. Godfrey, MD/Medical Director ) |
Study ID Numbers: | BNIT-PR-001 |
Study First Received: | February 25, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00629057 History of Changes |
Health Authority: | United States: Food and Drug Administration |
androgen-insensitive, non-metastatic, prostate, cancer |
Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Hormones Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Pharmacologic Actions Androgens |