Randomized Trial of Interleukin-2 (IL-2) as Early Consolidation Following Marrow Ablative 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. Three patients been have accrued (about 1 per month). Toxicity has been minimal to none. Two additional patients are being screened for enrollment. Our plan is complete accrual within 2 years, carrying over funds from ear 1-3.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2003
- Accession Number
- ADA420367
Entities
People
- Wolfram E. Samlowski
Organizations
- University of Utah