Overview

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

Status:
Completed
Trial end date:
2018-11-22
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BriaCell Therapeutics Corporation
Collaborator:
Cancer Insight, LLC
Treatments:
Cyclophosphamide
Interferon alpha-2
Interferon-alpha
Interferons
Criteria
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

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.

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:

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

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

11. Women who are pregnant or nursing.

12. 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.

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

14. 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.

15. 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).

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

17. Male breast cancer patients.

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