Status:
COMPLETED
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Male Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
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-regulator...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00425672
Start Date
September 1 2005
Last Update
December 5 2018
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109