Randomized Trial of Interleukin-2 (IL-2) as Early Consolidation Following Marrow Ablative Therapy with Stem Cell Rescue for Matastatic Breast Cancer

摘要

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. We are 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. Disease free survival and toxicity assessment represent major clinical aims (Specific aim 1). Immunologic effector mechanisms induced following MAT/SR by IL-2 infusion are being evaluated (Aim 2). This study opened 6/11/03. Fourteen patients have been accrued, all have completed planned treatment. Toxicity has been minimal. Laboratory correlation studies have been completed and the results of this trial will be submitted for publication in the next several months.