At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
ONTAK +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I-II Study of Denileukin Diftitox (ONTAK®) in Patients With Advanced Refractory Breast Cancer
In Brief
A Phase 2 clinical trial evaluating ONTAK, flow cytometry, and 4 other interventions for Male Breast Cancer and 5 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMale Breast Cancer, Recurrent Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2005
First PostedJan 2007
Primary CompletionApr 2010
TodayJul 2026
First PostedJan 23, 2007
Enrollment StartSep 1, 2005
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 19.4 years ago
Interventions
ONTAKbiological
Given IV
flow cytometryother
Correlative studies
immunohistochemistry staining methodother
Correlative studies
enzyme-linked immunosorbent assayother
Correlative studies
laboratory biomarker analysisother
Correlative studies
protein expression analysisgenetic
Correlative studies