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Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)

NCT00162929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-06-04

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.

Conditions

Interventions

BIOLOGICAL

AdHer-2/neu transduced dendritic cells

Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site)

Sponsors & Collaborators

  • Ontario Cancer Research Network

    collaborator NETWORK

  • Canadian Breast Cancer Research Alliance

    collaborator OTHER

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Sukhbinder Dhesy-Thind, M.D. · Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University

  • Ronan Foley, M.D. · McMaster University

  • Richard Tozer, M.D. · Juravinski Cancer Centre - Hamilton Health Sciences

  • Peter Ellis, M.D. · Juravinski Cancer Centre - Hamilton Health Sciences

  • Jack Gauldie, M.D. · McMaster University

  • Mark Levine, M.D. · Ontario Clinical Oncology Group (OCOG)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-07-31
Completion
2012-05-31

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Diseases

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 NCT00162929 on ClinicalTrials.gov