Randomized Trial in Interleukin-2 (IL-2) as Early Consolidation Following Marrow Ablation Therapy with Stem Cell Rescue for Metastatic Breast Cancer
Abstract
Interleukin-2 (IL-2) has the capacity to activate lymphocytes to kill multidrug resistant cancer cells. Our phase I data established the feasibility of administering a single course of low-dose IL-2 (1.6 million IU/m2/day as a continuous i.v. infusion for 18 days) as consolidation treatment to patients with metastatic breast cancer early after intensive chemotherapy. Seven patients (60%) remained in complete remission at a median of >435 days post stem cell transplantation. We are therefore performing a phase II trial of AC+T chemotherapy followed by IL-2 consolidation (1 cycle as described above) in high risk stage II and III breast cancer patients. The goal is to kill residual chemotherapy- resistant cancer cells. Disease free survival and toxicity assessment represent major clinical aims (Specific aim 1). Immunologic effector mechanisms induced following MAT/SR by IL-2 infusion will be evaluated using phenotypic and functional assays for LAK cell induction (Specific Aim 2). Accrual to this study has been delayed due to a change from a randomized trial to a single arm phase II study. After overcoming regulatory and legal issues, the study finally opened 6/11/03. Ten patients been have accrued, 9 have completed planned treatment. Toxicity has been minimal to none. Two additional patients are being screened for enrollment. Laboratory correlation studies are proceeding and preliminary results demonstrate activation of circulating lymphokine-activated killer.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2004
- Accession Number
- ADA433866
Entities
People
- Finn B. Peterson
- Wolfram E. Samlowski
Organizations
- University of Utah