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SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03066947
Recruitment Status : Completed
First Posted : March 1, 2017
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Cancer Insight, LLC
Information provided by (Responsible Party):
BriaCell Therapeutics Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breastcancer
Breast Neoplasm
Interventions Biological: SV-BR-1-GM
Drug: Cyclophosphamide
Biological: Interferon-alpha-2b
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Period Title: Overall Study
Started 24
Completed 14
Not Completed 10
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Patients with Advanced Breast Cancer
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
  79.2%
>=65 years
5
  20.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
24
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
2
   8.3%
Not Hispanic or Latino
22
  91.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   8.3%
White
22
  91.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Hide Description To evaluate the number of patients with toxicity events while on SV-BR-1-GM, as defined by the Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame Through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description:

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with Adverse Events
24
 100.0%
Erythema injection site
11
  45.8%
Pruritis injection site
8
  33.3%
Induration injection site
7
  29.2%
Fatigue
6
  25.0%
Nausea
6
  25.0%
Constipation
5
  20.8%
Abdominal pain
4
  16.7%
Flu like symptoms
4
  16.7%
Diarrhea
3
  12.5%
GGTP increased
3
  12.5%
Injection site reaction
3
  12.5%
Urinary Tract Infection
3
  12.5%
Vomiting
3
  12.5%
Abdominal distension
2
   8.3%
Alkaline Phosphatase Increased
2
   8.3%
ALT Increased
2
   8.3%
Anorexia
2
   8.3%
AST Increased
2
   8.3%
Back Pain
2
   8.3%
Chills
2
   8.3%
Decreased appetite
2
   8.3%
Dehydration
2
   8.3%
Dizziness
2
   8.3%
Erythema Multiforme
2
   8.3%
Glucose increased
2
   8.3%
Hematocrit Decreased
2
   8.3%
Hypercalcemia
2
   8.3%
Lymphocytes Decreased
2
   8.3%
Myalgia
2
   8.3%
Pleural Effusion
2
   8.3%
2.Secondary Outcome
Title Duration of Treatment Emergent Adverse Events [Safety]
Hide Description To evaluate the duration of toxicity events while on SV-BR-1-GM, as defined by CTCAE
Time Frame Through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Median Duration
Hide Arm/Group Description:
Median duration of adverse events
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: Days
8
(0 to 422)
3.Secondary Outcome
Title Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety]
Hide Description To evaluate the number of participants with an adverse event related to SV-BR-1-GM administration, as defined by CTCAE
Time Frame Through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Number with related adverse events
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description:

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
23
  95.8%
4.Secondary Outcome
Title Objective Tumor Response Rate
Hide Description Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors (RECIST) and immune-related RECIST (iRECIST) criteria.
Time Frame Through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description:

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Rate of Non-progression of Tumors
Hide Description Non-progressive rate, defined as CR, PR or stable disease (SD) per RECIST and iRECIST criteria
Time Frame Through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description:

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
4
  16.7%
6.Secondary Outcome
Title Durability of Tumor Response
Hide Description Durability of response, as defined as complete response (disappearance of all tumors), partial response (30% or greater reduction in the sum of diameters of target lesions (tumors) with stable disease in non-target lesions) or stable disease (less than 20% increase in the sum of diameters of target lesions with no new lesions appearing) by evaluating those patients eligible to complete the optional treatments from 9-12 months
Time Frame Through study completion, an average of 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description:

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: days
105.5
(79 to 197)
7.Other Pre-specified Outcome
Title Immune Responses to Vaccine
Hide Description To assess immune responses to SV-BR-1-GM, and to recall antigens, if any, as measured by DTH skin tests and/or other immunological tests
Time Frame Through study completion, an average of 1 year
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Quality of Life Using the SF-36 Health Survey
Hide Description To measure the quality of life (QOL) of participants using the SF-36 Health Survey, which includes measures of General Health, Limitations of Activity, Physical Health Problems, Emotional Health Problems, Social Activities, Energy and Emotions.
Time Frame Through study completion, an average of 1 year
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Weight
Hide Description To measure changes in weight.
Time Frame Through study completion, an average of 1 year
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Performance Status
Hide Description To measure changes in performance status using the Eastern Cooperative Oncology Group (ECOG) scale
Time Frame Through study completion, an average of 1 year
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Pain (Pain Scale)
Hide Description To measure changes in pain using a scale from None to Very Mild to Mild to Moderate to Severe to Very Severe
Time Frame Through study completion, an average of 1 year
Outcome Measure Data Not Reported
Time Frame up to 1 year
Adverse Event Reporting Description Used CTCAE V4.03 to determine adverse event intensity
 
Arm/Group Title SV-BR-1-GM Monotherapy
Hide Arm/Group Description

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation; SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2); Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation

SV-BR-1-GM: See above

Cyclophosphamide: Low dose pre-treatment to reduce regulatory T cells

Interferon-alpha-2b: Low dose given in the vaccine site to boost the immune response

All-Cause Mortality
SV-BR-1-GM Monotherapy
Affected / at Risk (%)
Total   3/24 (12.50%)    
Hide Serious Adverse Events
SV-BR-1-GM Monotherapy
Affected / at Risk (%) # Events
Total   8/24 (33.33%)    
Cardiac disorders   
Restrictive Cardiomyopathy * 2  1/24 (4.17%)  1
Palpitations * 2  1/24 (4.17%)  1
Gastrointestinal disorders   
GERD * 2  1/24 (4.17%)  1
General disorders   
Fever * 2  1/24 (4.17%)  1
Infections and infestations   
Sepsis * 1  1/24 (4.17%)  1
Urinary Tract Infection * 2  1/24 (4.17%)  1
Influenza A * 2  1/24 (4.17%)  1
Metabolism and nutrition disorders   
Dehydration * 2  1/24 (4.17%)  1
Hyponatremia * 2  1/24 (4.17%)  1
Worsening of Hypercalcemia * 2  1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders   
Bone Pain * 2  1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory Failure * 1  1/24 (4.17%)  1
1
Term from vocabulary, MedDRA (19.0)
2
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SV-BR-1-GM Monotherapy
Affected / at Risk (%) # Events
Total   24/24 (100.00%)    
Gastrointestinal disorders   
Nausea * 2  6/24 (25.00%)  8
Constipation * 2  5/24 (20.83%)  5
Abdominal pain * 2  4/24 (16.67%)  5
Diarrhea * 2  3/24 (12.50%)  5
Vomiting * 2  3/24 (12.50%)  3
Abdominal distension * 2  2/24 (8.33%)  2
General disorders   
Erythema, injection site * 1  11/24 (45.83%)  42
Pruritis, injection site * 2  8/24 (33.33%)  14
Induration, injection site * 2  7/24 (29.17%)  31
Fatigue * 2  6/24 (25.00%)  8
Flu like symptoms * 2  4/24 (16.67%)  5
Injection site reaction * 2  3/24 (12.50%)  3
Chills * 2  2/24 (8.33%)  2
Infections and infestations   
Urinary Tract Infection * 2  3/24 (12.50%)  3
Investigations   
GGTP increased * 2  3/24 (12.50%)  5
Alkaline Phosphatase Increased * 2  2/24 (8.33%)  4
ALT Increased * 2  2/24 (8.33%)  2
AST Increased * 2  2/24 (8.33%)  4
Glucose increased * 2  2/24 (8.33%)  2
Hematocrit Decreased * 2  2/24 (8.33%)  2
Lymphocytes Decreased * 2  2/24 (8.33%)  2
Metabolism and nutrition disorders   
Anorexia * 2  2/24 (8.33%)  2
Decreased appetite * 2  2/24 (8.33%)  2
Dehydration * 2  2/24 (8.33%)  2
Hypercalcemia * 2  2/24 (8.33%)  4
Musculoskeletal and connective tissue disorders   
Back Pain * 2  2/24 (8.33%)  2
Myalgia * 2  2/24 (8.33%)  2
Nervous system disorders   
Dizziness * 2  2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion * 2  2/24 (8.33%)  2
Skin and subcutaneous tissue disorders   
Erythema Multiforme * 2  2/24 (8.33%)  2
1
Term from vocabulary, MedDRA (19.0)
2
Term from vocabulary, MedDRA (20.0)
*
Indicates events were collected by non-systematic assessment
One patient dropped out after receiving cyclophosphamide and did not receive SV-BR-1-GM.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. William Williams
Organization: BriaCell Therapeutics Corporation
Phone: 1-888-485-6340
EMail: williams@briacell.com
Layout table for additonal information
Responsible Party: BriaCell Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT03066947    
Other Study ID Numbers: 0001
WRI-GEV-007 ( Other Identifier: BriaCell )
First Submitted: February 16, 2017
First Posted: March 1, 2017
Results First Submitted: December 10, 2019
Results First Posted: January 29, 2021
Last Update Posted: January 29, 2021