Stage IV Breast Cancer Clinical Trial
Official title:
Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of
immune cells from attacking the breast cancer cells.
PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects
to see how well it works in treating patients with advanced breast cancer that did not
respond to previous treatment.
PRIMARY OBJECTIVES:
I. To evaluate the safety of ONTAK infusion in patients with advanced refractory breast
cancer.
II. To evaluate the effect of ONTAK administration on peripheral blood T-regulatory cells.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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