NCT00425672

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment

Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ONTAK	Given IV
OTHER	flow cytometry	Correlative studies
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	enzyme-linked immunosorbent assay	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	protein expression analysis	Correlative studies

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-04-01
• First posted: 2007-01-23
• Last updated: 2018-12-05
• Results posted: 2017-08-04

Locations

1 site across 1 country: United States