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Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer

NCT01532960 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-05-08

No results posted yet for this study

Summary

Despite advances in surgical, radiation and medical therapies of early stage breast cancer, some patients will experience disease recurrence. Because recurrence may not happen for years after definitive treatment, there is a period of time between resection and relapse when micrometastatic disease may be amenable to immune eradication or modulation. While the ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast immunotherapy is to define treatments that have immunologic efficacy. In this study, the investigators will determine whether a vaccine consisting of nine-class I breast specific peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.

Conditions

Interventions

BIOLOGICAL

poly-ICLC

poly-ICLC

BIOLOGICAL

9 Peptides from Her-2/neu, CEA, & CTA

9 synthetic peptides derived from Her-2/neu, CEA \& CTA derived breast cancer proteins.

BIOLOGICAL

Peptide-tet

A class II MHC-restricted helper peptide derived from tetanus toxoid protein.

Sponsors & Collaborators

  • Craig L Slingluff, Jr

    lead OTHER

Principal Investigators

  • Patrick M Dillon, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-09-30
Completion
2015-09-30

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 NCT01532960 on ClinicalTrials.gov