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Vaccine Therapy in Treating Patients With Breast Cancer

NCT00524277 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2020-03-30

No results posted yet for this study

Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer.

PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.

Conditions

Interventions

BIOLOGICAL

GP2 peptide + GM-CSF vaccine

Given intradermally every 3-4 weeks for a total of up to 6 inoculations

BIOLOGICAL

GM-CSF (sargramostim)

GM-CSF given intradermally very 3-4 weeks for a total of up to 6 inoculations

BIOLOGICAL

AE37 + GM-CSF vaccine

Given intradermally every 3-4 weeks for a total of up to 6 inoculations

BIOLOGICAL

GM-CSF (sargramostim)

Given intradermally every 3-4 weeks for a total of up to 6 inoculations

Sponsors & Collaborators

  • NuGenerex Immuno-Oncology

    collaborator INDUSTRY

  • Norwell, Inc.

    collaborator INDUSTRY

  • San Antonio Military Medical Center

    lead FED

Principal Investigators

  • Elizabeth A Mittendorf, MD, FACS · UT M.D. Anderson Cancer Center

  • George E Peoples, MD, FACS · Cancer Vaccine Development Program, Department of Surgery, Brooke Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2014-12-31
Completion
2017-03-31

Countries

  • United States
  • Germany
  • Greece

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 NCT00524277 on ClinicalTrials.gov