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Immunotherapy Vaccine and Herceptin in Breast Cancer

NCT03014076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-09

No results posted yet for this study

Summary

The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following:

* Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab
* Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
* Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab

Conditions

  • Breastcancer

Interventions

DRUG

GP2 peptide + GM-CSF vaccine plus trastuzumab

HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab

DRUG

Trastuzumab

HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.

Sponsors & Collaborators

  • Cancer Insight, LLC

    lead INDUSTRY

Principal Investigators

  • George E Peoples, MD · Cancer Insight

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2016-01-31
Completion
2017-01-31

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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 NCT03014076 on ClinicalTrials.gov