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

Completed · Phase 1/Phase 2

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

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.

Key facts

Study ID

NCT00425672

Run by

University of Washington

People needed

15

Starts

2005-09-01

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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