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

NCT03066947 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 0001WRI-GEV-007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

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.

Conditions

Breastcancer; Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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)

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Duration of Treatment Emergent Adverse Events [Safety]

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

• Objective Tumor Response Rate

  Through study completion, an average of 1 year

• Rate of Non-progression of Tumors

  Through study completion, an average of 1 year

• Durability of Tumor Response

  Through study completion, an average of 1 year

Other Outcomes (5)

• Immune Responses to Vaccine

  Through study completion, an average of 1 year

• Quality of Life Using the SF-36 Health Survey

  Through study completion, an average of 1 year

• Weight

  Through study completion, an average of 1 year

Study Arms (1)

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

Biological: SV-BR-1-GM; Drug: Cyclophosphamide; Biological: Interferon-alpha-2b

Interventions

SV-BR-1-GM BIOLOGICAL

See above

SV-BR-1-GM Monotherapy

Cyclophosphamide DRUG

Low dose pre-treatment to reduce regulatory T cells

Also known as: Cytoxan

SV-BR-1-GM Monotherapy

Interferon-alpha-2b BIOLOGICAL

Low dose given in the vaccine site to boost the immune response

Also known as: Intron A

SV-BR-1-GM Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• 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
• \. 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)
• \. Be 18 years of age or older and female
• \. Have expected survival of at least 4 months
• \. Have adequate performance status (ECOG 0-2)
• \. Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression
• \. Have provided written informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BriaCell Therapeutics Corporation: lead
• Cancer Insight, LLC: collaborator

Study Sites (5)

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

University of Miami/Sylvester at Plantation

Plantation, Florida, 33324, United States

Location

Cancer Center of Kansas (CCK)

Wichita, Kansas, 67214, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Introns

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. William Williams
• Organization: BriaCell Therapeutics Corporation

williams@briacell.com

1-888-485-6340

Study Officials

• George E Peoples, MD, FACS

  Cancer Insight, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: May 5, 2017
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: January 29, 2021
• Results First Posted: January 29, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)