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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 2004-30 Sep 2005
UTAH UNIV SALT LAKE CITY
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Interleukin-2 IL-2 has the capacity to activate lymphocytes to kill multi-drug resistant cancer cells. Our phase I data established the feasibility of administering a single course of low-dose IL-2 1.6 million 1Um2day 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 I1 trial of ACT chemotherapy followed by IL-2 consolidation 1 cycle as described above in high risk stage I1 and 111 breast cancer patients. Disease free survival and toxicity assessment represent major clinical aims Specific aim 1. Immunologic effectors mechanisms induced following MATSR by IL-2 infusion are being evaluated Aim 2. This study opened 61103. Twelve patients been have accrued, 11 have completed planned treatment, 3 others are being screened. Two additional institutional sites are being added. Toxicity has been minimal to none. Two additional patients are being- screened for enrollment. Laboratory correlation studies are proceeding Our plan is complete accrual within 2 years, carrying over funds from preceding years.
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