Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
I. To evaluate the safety of ONTAK infusion in patients with advanced refractory breast
II. To evaluate the effect of ONTAK administration on peripheral blood T-regulatory cells.
I. To evaluate the incidence of IL-2R expression in tumor samples and investigate the
correlation of tumor IL-2R expression and tumor response to ONTAK therapy.
II. To evaluate levels of circulating sIL-2R before and after ONTAK therapy. III. To
evaluate the effect of ONTAK on endogenous tumor specific immunity. IV. To evaluate the
potential anti-tumor effects of ONTAK in patients with advanced refractory breast cancer.
Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to
6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and systemic toxicity as assessed by CTCAE v3.0
Initial evaluation, 3 weeks after cycles 2, 4, and 6
7 Days after last dose of ONTAK
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|