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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Male Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

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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 ConsortiumSeattle, Washington  98109