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Safety and Efficacy Study of HER2/Neu (E75) Vaccine in Node-Positive Breast Cancer Patients

NCT00841399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-31

No results posted yet for this study

Summary

The purposes of this study are the following:

1. To assess safety and document local and systemic toxicity to the peptide vaccine (E75)
2. To determine maximum tolerated dose (MTD) and optimal biologic dose (OBD) for the peptide vaccine
3. To evaluate the in vivo cellular immune response to the peptide vaccine
4. To evaluate time to recurrence in the vaccinated patients vs. matched controls

Conditions

Interventions

BIOLOGICAL

E75 + GM-CSF vaccine

Dose escalation scheme involving three patients each receiving injection of 100, 500, or 1,000 mcg E75 + GM-CSF monthly for 6 months. HLA-A2 and HLA-A3 status determined. HLA-A2+ and HLA-A3+ patients receive the vaccine; HLA-A2- and HLA-A3- enrolled to the control arm.

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • COL George Peoples, MD, FACS

    lead FED

Principal Investigators

  • George E Peoples, MD · Cancer Vaccine Development Program

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2012-09-30
Completion
2013-03-31

Countries

  • United States

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 NCT00841399 on ClinicalTrials.gov