Clinical trial · Interventional
ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
NCT00425672CI-TRIAL-00036010completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| ONTAK | Biological | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Biological: ONTAK
- Other: flow cytometry
- Other: immunohistochemistry staining method
- Other: enzyme-linked immunosorbent assay
- Other: laboratory biomarker analysis
- Genetic: protein expression analysis
Primary outcomes (2)
- measure
- Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0
- timeFrame
- 7 Days after last dose of ONTAK
- description
- Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.