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Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)

NCT00307229 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-06-04

No results posted yet for this study

Summary

To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent breast cancer.

Conditions

Interventions

BIOLOGICAL

adenoviral vector encoding rat Her-2/neu

Group 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles)

Sponsors & Collaborators

  • Ontario Cancer Research Network

    collaborator NETWORK

  • Canadian Breast Cancer Research Alliance

    collaborator OTHER

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Gerry Batist, M.D. · Lady Davis Institute for Medical Research Jewish General Hospital

  • Ronan Foley, M.D. · Hamilton Health Sciences Corporation

  • 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
2006-03-31
Primary Completion
2009-07-31
Completion
2012-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00307229 on ClinicalTrials.gov