drugset / Trial / NCT01532960

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

NCT01532960

Phase 1 Terminated 11 enrolled Craig L Slingluff, Jr
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-07
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject 9 Peptides from Her-2/neu, CEA, & CTA Vaccine 100 ug Intramuscular
Subject Hiltonol Other / unclassified 1 mg Intramuscular
Subject tetanus peptide melanoma vaccine Peptide 200 ug Intramuscular

Indications