Randomized Trial of Interleukin-2 (IL-2) as Early Consolidation Following Marrow Ablative Therapy With Stem Cell Rescue for Metastatic Breast Cancer
Annual rept. 1 Oct 2001-30 Sep 2002
UTAH UNIV SALT LAKE CITY
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Marrow ablative doses of chemotherapy followed by stem cell rescue MATSR produces a high frequency of objective responses in patients with metastatic breast cancer, with up to 40-50 complete responses. Unfortunately, responses tend to be short-lived. lnterleukin-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 IUm2day as a continuous i.v. infusion for l8 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 ACT 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 MATSR - 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 and due to negotiations between the University of Utah and the Army MRMC concerning liability clauses in the consent document.
- Medicine and Medical Research