Efficacy of Interleukin-2 in Triple Negative Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gregory Knapp
• Treatments: Aldesleukin

Criteria

Inclusion Criteria:

1. Women with biopsy proven TNBC who are not scheduled to receive neoadjuvant chemotherapy.

2. Tumors ≤ 2 cm (clinical T1N0)

3. Planned upfront surgery (patient preference)

4. Medically unable to receive neoadjuvant chemotherapy

5. 18 - 80 years of age.

6. Able to provide consent for the study.

7. Able to come to the hospital for the intralesional injections.

Exclusion Criteria:

1. No diagnosis of TNBC.

2. Not able to provide consent for the study.

3. Not able to come to the hospital for study visits.

4. Presence of any contraindication for IL-2 therapy (abnormal thallium stress test, abnormal pulmonary function test, organ allograft and toxicities with a previous dosage).

5. Participant has experienced IL-2 related toxicities during an earlier course of therapy (sustained ventricular tachycardia; cardiac arrythmias unresponsive to management; chest pain with ECG changes consistent with angina or myocardial infarction; cardiac tamponade; intubation required > 72 hours; renal failure requiring dialysis > 72 hours; coma, or toxic psychosis > 48 hours; repetitive or difficult to control seizures; bowel ischemia; gastrointestinal bleeding requiring surgery)

6. If participant is on cancer treatment drugs and steroids to avoid drug interactions.

7. Known pregnancy and breast feeding. There are no known studies to support the use of interleukin in pregnancy and breast-feeding mothers.