Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
18 Years
N/A
Both
Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
Trial Information
Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and systemic toxicity as assessed by CTCAE v3.0
Outcome Description:
Initial evaluation, 3 weeks after cycles 2, 4, and 6
Outcome Time Frame:
7 Days after last dose of ONTAK
Safety Issue:
Yes
Principal Investigator
Lupe Salazar
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Federal Government
Study ID:
6308
NCT ID:
NCT00425672
Start Date:
September 2005
Completion Date:
Related Keywords:
- Male Breast Cancer
- Recurrent Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
- Breast Neoplasms
- Breast Neoplasms, Male
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
