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

Sponsor:	BN ImmunoTherapeutics
Information provided by:	BN ImmunoTherapeutics
ClinicalTrials.gov Identifier:	NCT00629057

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by BN ImmunoTherapeutics:

Primary Outcome Measures:

To evaluate the safety and tolerability of single and multiple injection regimens of MVA-BN®-PRO for the treatment of androgen-insensitive prostate cancer. [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Continuous ] [ Designated as safety issue: No ]

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
1: Experimental Lowest dose level	Biological: MVA-BN-PRO 1x10e8 TCID50 q 4 wks x 6
2: Experimental Middle level dose	Biological: MVA-BN-PRO 2 x 10e8 TCID50 q 4 wks x 6
3: Experimental Highest dose level	Biological: MVA-BN-PRO 4 x 10e8 TCID50 q 4 wks x 6

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 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)

Cohort 1: 1 sc injection every 4 weeks x 3; retreated once at the same dose and schedule.
Cohort 2: 2 sc injections every 4 weeks x 3; retreated once at the same dose and schedule.
Cohort 3: 4 sc injections every 4 weeks x 3; retreated once at the same dose and schedule.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629057

Locations

United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, United States, 28173
United States, Tennessee
Urology Associates
Nashville, Tennessee, United States, 37209
United States, Texas
Urology Clinics of North Texas, PA
Dallas, Texas, United States, 75231
Urology Associates of South Texas
McAllen, Texas, United States, 78503

Sponsors and Collaborators

BN ImmunoTherapeutics

Investigators

Study Director:

Wayne R Godfrey, MD

BN ImmunoTherapeutics, Inc.

More Information

No publications provided

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:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00629057 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by BN ImmunoTherapeutics:

androgen-insensitive, non-metastatic, prostate, cancer

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 09, 2009