MedTrace Logo

ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment

NCT00425672 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-12-05

Study results available
· View outcomes & findings →

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.

Conditions

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Interventions

BIOLOGICAL

ONTAK

Given IV

OTHER

flow cytometry

Correlative studies

OTHER

immunohistochemistry staining method

Correlative studies

OTHER

enzyme-linked immunosorbent assay

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

GENETIC

protein expression analysis

Correlative studies

Sponsors & Collaborators

Principal Investigators

  • Lupe Salazar · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425672 on ClinicalTrials.gov