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A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer (BNIT-PR-001)

Primary Purpose

Androgen-insensitive Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MVA-BN-PRO
MVA-BN-PRO
MVA-BN-PRO
Sponsored by
Bavarian Nordic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgen-insensitive Prostate Cancer focused on measuring androgen-insensitive, non-metastatic, prostate, cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Centers of Alabama
  • Walter Reed Army Medical Center
  • Lawrenceville Urology
  • Presbyterian Hospital Center for Cancer Research
  • Urology Associates
  • Urology Clinics of North Texas, PA
  • Urology Associates of South Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Lowest dose level

Middle level dose

Highest dose level

Outcomes

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.

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.

Full Information

First Posted
February 25, 2008
Last Updated
March 12, 2019
Sponsor
Bavarian Nordic
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1. Study Identification

Unique Protocol Identification Number
NCT00629057
Brief Title
A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
Acronym
BNIT-PR-001
Official Title
An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgen-insensitive Prostate Cancer
Keywords
androgen-insensitive, non-metastatic, prostate, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lowest dose level
Arm Title
2
Arm Type
Experimental
Arm Description
Middle level dose
Arm Title
3
Arm Type
Experimental
Arm Description
Highest dose level
Intervention Type
Biological
Intervention Name(s)
MVA-BN-PRO
Intervention Description
1x10e8 TCID50 q 4 wks x 6
Intervention Type
Biological
Intervention Name(s)
MVA-BN-PRO
Intervention Description
2 x 10e8 TCID50 q 4 wks x 6
Intervention Type
Biological
Intervention Name(s)
MVA-BN-PRO
Intervention Description
4 x 10e8 TCID50 q 4 wks x 6
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Bandman
Organizational Affiliation
Bavarian Nordic
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Presbyterian Hospital Center for Cancer Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28173
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Urology Clinics of North Texas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology Associates of South Texas
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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