Overview

Efficacy of Interleukin-2 in Triple Negative Breast Cancer

Status:
Not yet recruiting
Trial end date:
2025-04-01
Target enrollment:
Participant gender:
Summary
This study is a single arm, non-randomized experimental study design. It will provide us opportunity to conduct a pilot study to evaluate the efficacy of an intralesional immunotherapy (e.g. IL-2) in early stage TNBC as a well-tolerated, low-risk intervention with the potential to improve outcomes without the toxicity of systemic treatment. Following are the objectives of this study: 1. Utilize new and existing infrastructure within the Breast Health and Women Program at the IWK to conduct the institutions first surgery-driven breast cancer trial 2. Evaluate the feasibility of patient accrual in a window of opportunity trial design 3. Evaluate the efficacy of intralesional IL-2 to produce a pathologic response in TNBC. The participants with TNBC will be receiving 3-4 injections of Interleukin-2. Total dose per injection is 25 million international units per mm width of tumor to max dose of 10 million IU. Half of total dose will be injected in the center of lesion/tumor and remaining half of total dose at periphery / peri-tumoral.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Gregory Knapp
Treatments:
Aldesleukin