BreastcancerPhase 1/2NCT03066947
SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
A Phase 1/2 study testing SV-BR-1-GM, Cyclophosphamide and Interferon-alpha-2b in people with Breastcancer and Breast Neoplasm, run by BriaCell Therapeutics Corporation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breastcancer, Breast Neoplasm
- What is being tested?
- SV-BR-1-GM, Cyclophosphamide and Interferon-alpha-2b
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 May 2017to 22 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- There is no need for steroids and patients have not had steroids at least 2 weeks
- No individual tumor size is >50 mm3
- ECOG status <3
- Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
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- If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
- 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
- 2. 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)
- 3. Be 18 years of age or older and female
- 4. Have expected survival of at least 4 months
- 5. Have adequate performance status (ECOG 0-2)
- 6. Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression
- 7. Have provided written informed consent.
Who cannot join
- 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).
- 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.
- BUN >30 and a creatinine >2.
- Absolute granulocyte count < 1000; platelets <100,000.
- Bilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x ULN.
- Proteinuria >1+ on urinalysis or >1 gm/24hr.
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- 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.
- New York Heart Association stage 3 or 4 cardiac disease.
- A pleural effusion of moderate severity or worse.
- Any woman of childbearing potential, unless she:
- Agrees to take measures to avoid becoming pregnant during the study and
- Has a negative serum pregnancy test within 7 days prior to starting treatment.
- Women who are pregnant or nursing.
- 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.
- Patients who are HIV positive (by self-report) or have clinical or laboratory features indicative of AIDS.
- 14. 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.
- 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).
- Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the PI.
- Male breast cancer patients.
- Patients may not be on a concurrent clinical trial, unless approved by PI.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Providence Regional Medical Center
Everett, Washington, 98201
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Miami/Sylvester at Plantation
Plantation, Florida, 33324
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403
Cancer Center of Kansas (CCK)
Wichita, Kansas, 67214
About this study
Official title: A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients
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.
Read the 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:
- Inquire regarding events of past weeks, change in medications, pain scale, ECOG scale, and review of systems.
- Check injection sites.
- 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.
- 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.
- Conditions
- Breastcancer, Breast Neoplasm
- Being tested
- SV-BR-1-GM, Cyclophosphamide, Interferon-alpha-2b
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SV-BR-1-GMBiological
See above
CyclophosphamideDrug
Also called Cytoxan
Low dose pre-treatment to reduce regulatory T cells
Interferon-alpha-2bBiological
Also called Intron A
Low dose given in the vaccine site to boost the immune response
| Study group | Role | What they receive |
|---|---|---|
| SV-BR-1-GM Monotherapy | Experimental | 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 Receives: Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Biological: Interferon-alpha-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
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)
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Duration of Treatment Emergent Adverse Events [Safety]
To evaluate the duration of toxicity events while on SV-BR-1-GM, as defined by CTCAE
Measured: Through study completion, an average of 1 year
Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety]
To evaluate the number of participants with an adverse event related to SV-BR-1-GM administration, as defined by CTCAE
Measured: Through study completion, an average of 1 year
Objective Tumor Response Rate
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.
Measured: Through study completion, an average of 1 year
Rate of Non-progression of Tumors
Non-progressive rate, defined as CR, PR or stable disease (SD) per RECIST and iRECIST criteria
Measured: Through study completion, an average of 1 year
Durability of Tumor Response
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start5 May 2017
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- BriaCell Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Insight, LLC
- Responsible party
- Sponsor
- Investigators
- George E Peoples, MD, FACS, Study director, Cancer Insight, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066947
- Sponsor's protocol ID
- 0001
- Other IDs
- WRI-GEV-007
- Status last verified
- Dec 2019
- First submitted
- 16 Feb 2017
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03066947
- Acronym / sponsor ID
- 0001
- Conditions
- Breastcancer, Breast Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BriaCell Therapeutics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Insight, LLC
- Study start
- 5 May 2017 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Inquire regarding events of past weeks, change in medications, pain scale, ECOG scale, and review of systems.
- Check injection sites.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SV-BR-1-GM Monotherapy | Experimental | Biological: SV-BR-1-GM, Drug: Cyclophosphamide, Biological: Interferon-alpha-2bPretreatment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site.
- 2. 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)
- 3. Be 18 years of age or older and female
- 4. Have expected survival of at least 4 months
- 5. Have adequate performance status (ECOG 0-2)
Key exclusion criteria (20 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SV-BR-1-GMSee above | Biological | SV-BR-1-GM Monotherapy |
| CyclophosphamideAlso: CytoxanLow dose pre-treatment to reduce regulatory T cells | Drug | SV-BR-1-GM Monotherapy |
| Interferon-alpha-2bAlso: Intron ALow dose given in the vaccine site to boost the immune response | Biological | SV-BR-1-GM Monotherapy |
Primary outcome
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Time frame: 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)
5 secondary outcomes
Duration of Treatment Emergent Adverse Events [Safety]
Time frame: Through study completion, an average of 1 year
Number of Participants With an Adverse Event Related to SV-BR-1-GM Administration [Safety]
Time frame: Through study completion, an average of 1 year
Objective Tumor Response Rate
Time frame: Through study completion, an average of 1 year
Rate of Non-progression of Tumors
Time frame: Through study completion, an average of 1 year
Durability of Tumor Response
Time frame: Through study completion, an average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George E Peoples, MD, FACS study director
Cancer Insight, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SV-BR-1-GM, Cyclophosphamide and Interferon-alpha-2b in people with Breastcancer and Breast Neoplasm, run by BriaCell Therapeutics Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety] (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.