Phase 2
Completed N=15
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
male breast cancer · Recurrent Breast Cancer · Stage IIIA Breast Cancer · Stage IIIB Breast Cancer
Source: ClinicalTrials.gov NCT00425672 ↗
Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Aug 2017
Primary outcomePrimary: Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0 — 15 Participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0 |
15 | — |
| PRIMARY Efficacy of ONTAK in Depleting T-regulatory Cells as a Decrease in Peripheral Blood Tregs Using Flow Cytometry |
4 | — |
| SECONDARY Incidence of Interleukin-2 (IL-2) and IL-2 Receptor (IL-2R) Expression in Tumor Samples by Immunohistochemical (IHC) Analysis |
8; 6 | — |
| SECONDARY Presence of Circulating sIL-2R in the Peripheral Blood |
4.8; 8.1; 34.8; 17.7 | — |
| SECONDARY Presence of Endogenous Tumor-specific Immunity |
10 | — |
| SECONDARY Anti-tumor Effects of ONTAK Determined by Tumor Response and Progression |
0; 0; 10; 4 | — |
Eligibility Criteria
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 = = 60 ml/min
- ALT/AST = = 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
Data sourced from ClinicalTrials.gov (NCT00425672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.