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

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Biological: poly-ICLC; Biological: 9 Peptides from Her-2/neu, CEA, & CTA; Biological: Peptide-tet

• Registration Number: NCT01532960
• Lead Sponsor: Craig L Slingluff, Jr

Brief 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.

Detailed Description

The study is a single arm, open label, pilot study of safety and immune efficacy of peptide vaccination with poly-ICLC in patients with stage IB-IIIA resected breast cancer. Participants will be patients who have completed their last dose/treatment of any single treatment or combination of adjuvant surgery, radiation, chemotherapy or trastuzumab therapy between 45 days and 6 months (180 days) prior to enrollment.

Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. All participants will receive 9 class I MHC-restricted synthetic peptides (restricted by HLA-A1, -A2, -A3, or -A31) and a class II MHC-restricted tetanus helper peptide mixed with 1mg poly-ICLC and administered in sterile water. The vaccine will be administered intramuscular (IM) (1 ml) and intradermally (ID) (1 ml) at vaccination sites in the arm and leg. (Each vaccine given IM and ID at one site; site to alternate between arm site opposite the breast cancer and an anterior thigh site.) Participants will be screened for HLA type and must be HLA-A1, -A2, -A3, or -A31 (80% of the Virginia population in prior studies1).

Annual follow-up for progression and survival for 3 years after study withdrawal/completion.

Study Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-15
• Study Start: 2012-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC	9 Peptides from Her-2/neu, CEA, & CTA	9 class I MHC-restricted synthetic peptides (100 mcg each peptide) derived from breast cancer associated proteins, a class II MHC-restricted tetanus derived peptide (200 mcg), plus polyICLC (1 mg).
9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC	poly-ICLC	9 class I MHC-restricted synthetic peptides (100 mcg each peptide) derived from breast cancer associated proteins, a class II MHC-restricted tetanus derived peptide (200 mcg), plus polyICLC (1 mg).
9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC	Peptide-tet	9 class I MHC-restricted synthetic peptides (100 mcg each peptide) derived from breast cancer associated proteins, a class II MHC-restricted tetanus derived peptide (200 mcg), plus polyICLC (1 mg).

Primary Outcome Measures

Name	Time	Method
Safety (Frequency of dose limiting adverse events)	30 days post-administration of the last vaccine
Immune response rate	through day 108	Measured as the number of IFN-gamma producing cells in the blood in response to the vaccine.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity- CD8+ cytokine production	through day 108	Estimate the Tc1/Tc2 cytokine production bias of circulating vaccine-specific T cells.
Immunogenicity- immue responses among subjects treated with anti-estrogen therapies	through day 108	Using the ELIspot assay, describe the frequency of immune responses among patients treated with anti-estrogen therapies
Safety (adverse event profile)	30 days post-administration of the last vaccine
Immunogenicity- CD8+ T cell specificity	through day 108	Characterize vaccine specific peripheral CD8+ T-cell specificity by tetramer staining and flow cytometric analysis

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States