This trial is active, not recruiting.

Conditions male breast cancer, recurrent breast cancer, stage iiia breast cancer, stage iiib breast cancer, stage iiic breast cancer, stage iv breast cancer
Treatments ontak, flow cytometry, immunohistochemistry staining method, enzyme-linked immunosorbent assay, laboratory biomarker analysis, protein expression analysis
Phase phase 1/phase 2
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date September 2005
End date April 2010
Trial size 15 participants
Trial identifier NCT00425672, 127, 6308, NCI-2010-00800, NCT00364208


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
ontak DAB389 interleukin-2
Given IV
flow cytometry
Correlative studies
immunohistochemistry staining method immunohistochemistry
Correlative studies
enzyme-linked immunosorbent assay ELISA
Correlative studies
laboratory biomarker analysis
Correlative studies
protein expression analysis
Correlative studies

Primary Outcomes

Safety and systemic toxicity as assessed by CTCAE v3.0
time frame: 7 Days after last dose of ONTAK
Efficacy of ONTAK in depleting T-regulatory cells
time frame: 21 days after cycle 6

Secondary Outcomes

Incidence of interleukin-2 (IL-2) and IL-2 receptor (IL-2R) expression in tumor samples
time frame: 21 days after cycle 6
Presence of circulating sIL-2R in the peripheral blood
time frame: 21 days after cycle 6
Presence of endogenous tumor-specific immunity
time frame: 21 days after cycle 6
Anti-tumor effects of ONTAK determined by tumor response and progression
time frame: 21 days after cycle 6

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with advanced stage refractory breast cancer - Progressive or relapsed disease following standard therapy - Patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as >= 20 mm with conventional CT techniques or >= 10 mm with spiral CT scan; measurable (bi-dimensional) chest wall disease will also be allowed - Patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible - White blood cell count (WBC) > 3.0 THOU/ul - ANC > 1.0 THOU/ul - Platelets >= 100 THOU/ul - Serum creatinine =< 2.0 mg/dL or creatinine clearance (calculated) >= 60 ml/min - ALT/AST =< 2.0 x upper limit of normal - Total bilirubin =< 1.5 x upper limit of normal - Albumin >= 3.0 g/dL - Subjects must have a Performance Status Score (ECOG Scale) =< 2 - Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment - Men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ONTAK treatment is discontinued Exclusion Criteria: - Prior treatment with ONTAK (DAB389 IL-2) or DAB486 IL-2 - Known history of hypersensitivity to diphtheria toxin or IL-2 - Active autoimmune disease - Known history of pulmonary disease except controlled asthma - History of or pre-existing, cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization - Pregnant or breast-feeding women

Additional Information

Official title Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
Principal investigator Lupe Salazar
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Washington.