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

NCT03066947 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-01-29

Study results available
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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

Interventions

BIOLOGICAL

SV-BR-1-GM

See above

DRUG

Cyclophosphamide

Low dose pre-treatment to reduce regulatory T cells

BIOLOGICAL

Interferon-alpha-2b

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

Sponsors & Collaborators

  • Cancer Insight, LLC

    collaborator INDUSTRY

  • BriaCell Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • George E Peoples, MD, FACS · Cancer Insight, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2018-11-22
Completion
2018-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066947 on ClinicalTrials.gov