Randomized Trial of Interleukin-2 (IL-2) as Early Consolidation Following Marrow Ablative Therapy with Stem Cell Rescue for Metastatic Breast Cancer
Abstract
Marrow ablative doses of chemotherapy followed by stem cell rescue (MAT/SR) produce 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. Interleukin-2 (IL-2) can activate lymphocytes to kill multidrug resistant cancer cells. Our phase I data established that 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 earl after MAT/SR. Seven patients (60%) remained in complete remission at a median of 435 days (range: 24 - 720 days) post stem cell transplantation. We are therefore performing a larger scale phase II trial of MAT/SR, followed by a single 18-day continuous infusion of low-dose IL-2 to activate lymphocytes 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 and due to negotiations between the University of Utah and the Army MRMC concerning liability clauses in the consent document. A finalized protocol has now been agreed upon.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2000
- Accession Number
- ADA388772
Entities
People
- Wolfram E. Samlowski
Organizations
- University of Utah