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

• Sponsor: BriaCell Therapeutics Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03066947
• Collaborator: Cancer Insight, LLC (Industry)
• Enrollment: 24
• Locations: 5
• Arm: 1
• Actual Duration (Months): 18.6
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation ~2 and ~4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.

Condition or Disease	Intervention/Treatment	Phase
Breastcancer; Breast Neoplasm	Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Biological: Interferon-alpha-2b	Phase 1/Phase 2

Detailed Description

This is a single arm, open label study of SV-BR-1-GM in recurrent and/or metastatic breast cancer. The detailed treatment regimen follows:

Pre-Inoculation Regimen:

Cyclophosphamide (Cytoxan) 300 mg/m^{2 I.V., 1x only, will be given 48-72 hours before each SV-BR-1-GM inoculation, with an antiemetic of the provider's choice (steroids prohibited). If the patient is not tolerating the cyclophosphamide, a lower dose may be used (e.g. 200 or 150 mg/m}2) or it may be withheld, with the Sponsor's approval.

Innoculation Day Standard Operating Procedures:

1. Inquire regarding events of past weeks, change in medications, pain scale, ECOG scale, and review of systems.

2. Check injection sites.

3. Perform DTH skin test intra-dermally with the SV-BR-1 parent cell line (~1 x 10^6 irradiated tumor cells). Observe about 20 minutes for acute hypersensitivity. Grade III or higher acute hypersensitivity will abort therapy.

4. Inject SV-BR-1-GM intra-dermally into 4 sites in thighs and upper back (0.5 mL each). Monitor patients for 60 minutes. Vital signs will be assessed and medical attention will be warranted if unstable.

SV-BR-1-GM Preparation & Inoculation Regimen:

Each inoculation will be administered via intra-dermal injection at the investigational sites. Subjects will receive 15-25 x 10^6 viable, irradiated transfected breast tumor cells in a total volume of 2.0 ml Ringer's lactate. SV-BR-1-GM cells will be irradiated to ensure cell replication incompetency.

SV-BR-1-GM will be divided into four aliquots of 0.5 mL each and injected intra-dermally; one each into the anterior skin of the subject's right and left thighs and over the right and left upper back . Application of anesthetic lidocaine crème may be used if necessary for control of local pain before inoculation. Subjects will be monitored for 60 minutes.

After at least 10 subjects have been treated safely with this regimen, the dose of SV-BR-1-GM may be escalated or decreased in subsequent patients based on the emerging data.

Post-Inoculation Regimen:

2 days (± 1 day) after inoculation, and again 4 days (± 1 day) later after inoculation, the patient will return to the principal investigator's office to receive Interferon-alpha-2b (Merck) in 0.1 mL saline, prepared as follows: These will also be provided by the sponsor and injected intra-dermally to each inoculation site, beneath the thickest area. Again, subjects will be observed about 20 minutes. The DTH response will also be recorded at the 2 days (± 1 day) visit.

This cycle will be performed every 2 weeks for the first month of treatment (3 inoculations), and then every month for up to one year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients
• Actual Study Start Date: May 5, 2017
• Actual Primary Completion Date: Nov 22, 2018
• Actual Study Completion Date: Nov 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SV-BR-1-GM Monotherapy 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	Biological: SV-BR-1-GM; See above; Drug: Cyclophosphamide; Low dose pre-treatment to reduce regulatory T cells; Other Names: Cytoxan ; Biological: Interferon-alpha-2b; Low dose given in the vaccine site to boost the immune response; Other Names: Intron A

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety] [Through study completion, an average of 1 year]

   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)

Secondary Outcome Measures

1. Duration of Treatment Emergent Adverse Events [Safety] [Through study completion, an average of 1 year]

   To evaluate the duration of toxicity events while on SV-BR-1-GM, as defined by CTCAE

2. Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety] [Through study completion, an average of 1 year]

   To evaluate the number of participants with an adverse event related to SV-BR-1-GM administration, as defined by CTCAE

3. Objective Tumor Response Rate [Through study completion, an average of 1 year]

   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.

4. Rate of Non-progression of Tumors [Through study completion, an average of 1 year]

   Non-progressive rate, defined as CR, PR or stable disease (SD) per RECIST and iRECIST criteria

5. Durability of Tumor Response [Through study completion, an average of 1 year]

   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

Other Outcome Measures

1. Immune Responses to Vaccine [Through study completion, an average of 1 year]

   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

2. Quality of Life Using the SF-36 Health Survey [Through study completion, an average of 1 year]

   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.

3. Weight [Through study completion, an average of 1 year]

   To measure changes in weight.

4. Performance Status [Through study completion, an average of 1 year]

   To measure changes in performance status using the Eastern Cooperative Oncology Group (ECOG) scale

5. Pain (Pain Scale) [Through study completion, an average of 1 year]

   To measure changes in pain using a scale from None to Very Mild to Mild to Moderate to Severe to Very Severe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site.

• Patients with new or progressive breast cancer metastatic to brain will be eligible provided:

1. There is no need for steroids and patients have not had steroids at least 2 weeks

2. No individual tumor size is >50 mm3

3. ECOG status <3

4. Tumor is not impinging on Middle Cerebral Artery/speech-motor strip

5. If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia

6. Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids

7. Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)

8. Be 18 years of age or older and female

9. Have expected survival of at least 4 months

10. Have adequate performance status (ECOG 0-2)

11. Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression

12. Have provided written informed consent.

Exclusion Criteria:

1. Concurrent or recent chemotherapy (within 3 weeks), XRT within 3 weeks, may have had immunotherapy in the past (off within 3 weeks), or general anesthesia/major surgery (within 3 weeks). Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free "washout" period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).

2. History of clinical hypersensitivity to GM-CSF, Interferon-alpha-2b (Merck), yeast, beef, or to any components used in the preparation of the experimental vaccine.

3. BUN >30 and a creatinine >2.

4. Absolute granulocyte count < 1000; platelets <100,000.

5. Bilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN.

6. Proteinuria >1+ on urinalysis or >1 gm/24hr.

7. Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions specific testing range. This assessment may be repeated once at the discretion of the Investigator with the approval of the Sponsor.

8. New York Heart Association stage 3 or 4 cardiac disease.

9. A pleural effusion of moderate severity or worse.

10. Any woman of childbearing potential, unless she:

11. Agrees to take measures to avoid becoming pregnant during the study and

12. Has a negative serum pregnancy test within 7 days prior to starting treatment.

13. Women who are pregnant or nursing.

14. Patients with concurrent second malignancy. Persons with previous malignancies effectively treated and not requiring treatment for >24 months are eligible, provided there is unambiguous documentation that current local recurrence or metastatic site represents recurrence of the primary breast malignancy.

15. Patients who are HIV positive (by self-report) or have clinical or laboratory features indicative of AIDS.

16. 1. Patients who require systemic steroids at a dose equivalent of >10 mg/day of prednisone. Beta-blocker therapy, while not exclusionary, is discouraged and alternatives should be sought if possible. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis. Anticoagulants must be approved by the Investigator with notification of the Sponsor.

17. Patients who are on treatment for rheumatological or autoimmune disease unless approved by the Investigator in consultation with the Sponsor (e.g., as for replacement therapy for autoimmune thyroiditis or diabetes).

18. Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the PI.

19. Male breast cancer patients.

20. Patients may not be on a concurrent clinical trial, unless approved by PI.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph Heritage Healthcare	Santa Rosa	California	United States	95403
2	University of Miami/Sylvester at Plantation	Plantation	Florida	United States	33324
3	Cancer Center of Kansas (CCK)	Wichita	Kansas	United States	67214
4	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
5	Providence Regional Medical Center	Everett	Washington	United States	98201

Sponsors and Collaborators

• BriaCell Therapeutics Corporation
• Cancer Insight, LLC

Investigators

• Study Director: George E Peoples, MD, FACS, Cancer Insight, LLC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 11, 2018

More Information

Additional Information:

• Sponsor Website
• CRO Website

Publications

None provided.

• Responsible Party: BriaCell Therapeutics Corporation
• ClinicalTrials.gov Identifier: NCT03066947
• Other Study ID Numbers: 0001; WRI-GEV-007
• First Posted: Mar 1, 2017
• Last Update Posted: Jan 29, 2021
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Interferons; Interferon-alpha; Interferon alpha-2; Cyclophosphamide

Study Results

Participant Flow

Arm/Group Title	SV-BR-1-GM Monotherapy
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

Baseline Characteristics

Arm/Group Title	SV-BR-1-GM Monotherapy
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 Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 79.2%
>=65 years	5 20.8%
Sex: Female, Male (Count of Participants)
Female	24 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8.3%
Not Hispanic or Latino	22 91.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 8.3%
White	22 91.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
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

Outcome Measure Data

Analysis Population Description

All patients

Arm/Group Title	SV-BR-1-GM Monotherapy
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
Measure Participants	24
Patients with Adverse Events	24 100%
Erythema injection site	11 45.8%
Pruritis injection site	8 33.3%
Induration injection site	7 29.2%
Fatigue	6 25%
Nausea	6 25%
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]
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Median Duration
Arm/Group Description	Median duration of adverse events
Measure Participants	24
Median (Full Range) [Days]	8

3. Secondary Outcome

Title	Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety]
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

Outcome Measure Data

Analysis Population Description

Number with related adverse events

Arm/Group Title	SV-BR-1-GM Monotherapy
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
Measure Participants	24
Count of Participants [Participants]	23 95.8%

4. Secondary Outcome

Title	Objective Tumor Response Rate
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SV-BR-1-GM Monotherapy
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
Measure Participants	24
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Rate of Non-progression of Tumors
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SV-BR-1-GM Monotherapy
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
Measure Participants	24
Count of Participants [Participants]	4 16.7%

6. Secondary Outcome

Title	Durability of Tumor Response
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SV-BR-1-GM Monotherapy
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
Measure Participants	24
Median (Full Range) [days]	105.5

7. Other Pre-specified Outcome

Title	Immune Responses to Vaccine
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Quality of Life Using the SF-36 Health Survey
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Weight
Description	To measure changes in weight.
Time Frame	Through study completion, an average of 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Performance Status
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Other Pre-specified Outcome

Title	Pain (Pain Scale)
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

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
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 (%)	# Events
Total	3/24 (12.5%)
Serious Adverse Events
	SV-BR-1-GM Monotherapy
	Affected / at Risk (%)	# Events
Total	8/24 (33.3%)
Cardiac disorders
Restrictive Cardiomyopathy	1/24 (4.2%)	1
Palpitations	1/24 (4.2%)	1
Gastrointestinal disorders
GERD	1/24 (4.2%)	1
General disorders
Fever	1/24 (4.2%)	1
Infections and infestations
Sepsis	1/24 (4.2%)	1
Urinary Tract Infection	1/24 (4.2%)	1
Influenza A	1/24 (4.2%)	1
Metabolism and nutrition disorders
Dehydration	1/24 (4.2%)	1
Hyponatremia	1/24 (4.2%)	1
Worsening of Hypercalcemia	1/24 (4.2%)	1
Musculoskeletal and connective tissue disorders
Bone Pain	1/24 (4.2%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	SV-BR-1-GM Monotherapy
	Affected / at Risk (%)	# Events
Total	24/24 (100%)
Gastrointestinal disorders
Nausea	6/24 (25%)	8
Constipation	5/24 (20.8%)	5
Abdominal pain	4/24 (16.7%)	5
Diarrhea	3/24 (12.5%)	5
Vomiting	3/24 (12.5%)	3
Abdominal distension	2/24 (8.3%)	2
General disorders
Erythema, injection site	11/24 (45.8%)	42
Pruritis, injection site	8/24 (33.3%)	14
Induration, injection site	7/24 (29.2%)	31
Fatigue	6/24 (25%)	8
Flu like symptoms	4/24 (16.7%)	5
Injection site reaction	3/24 (12.5%)	3
Chills	2/24 (8.3%)	2
Infections and infestations
Urinary Tract Infection	3/24 (12.5%)	3
Investigations
GGTP increased	3/24 (12.5%)	5
Alkaline Phosphatase Increased	2/24 (8.3%)	4
ALT Increased	2/24 (8.3%)	2
AST Increased	2/24 (8.3%)	4
Glucose increased	2/24 (8.3%)	2
Hematocrit Decreased	2/24 (8.3%)	2
Lymphocytes Decreased	2/24 (8.3%)	2
Metabolism and nutrition disorders
Anorexia	2/24 (8.3%)	2
Decreased appetite	2/24 (8.3%)	2
Dehydration	2/24 (8.3%)	2
Hypercalcemia	2/24 (8.3%)	4
Musculoskeletal and connective tissue disorders
Back Pain	2/24 (8.3%)	2
Myalgia	2/24 (8.3%)	2
Nervous system disorders
Dizziness	2/24 (8.3%)	2
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	2/24 (8.3%)	2
Skin and subcutaneous tissue disorders
Erythema Multiforme	2/24 (8.3%)	2

Limitations/Caveats

One patient dropped out after receiving cyclophosphamide and did not receive SV-BR-1-GM.

More Information

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.