Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41)
Biological: 9 Peptides from Her-2/neu, CEA, & CTA
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage I-IV Breast Cancer|
- Safety (Frequency of dose limiting adverse events) [ Time Frame: 30 days post-administration of the last vaccine ] [ Designated as safety issue: Yes ]
- Immune response rate [ Time Frame: through day 108 ] [ Designated as safety issue: No ]Measured as the number of IFN-gamma producing cells in the blood in response to the vaccine.
- Safety (adverse event profile) [ Time Frame: 30 days post-administration of the last vaccine ] [ Designated as safety issue: Yes ]
- Immunogenicity- CD8+ T cell specificity [ Time Frame: through day 108 ] [ Designated as safety issue: No ]Characterize vaccine specific peripheral CD8+ T-cell specificity by tetramer staining and flow cytometric analysis
- Immunogenicity- CD8+ cytokine production [ Time Frame: through day 108 ] [ Designated as safety issue: No ]Estimate the Tc1/Tc2 cytokine production bias of circulating vaccine-specific T cells.
- Immunogenicity- immue responses among subjects treated with anti-estrogen therapies [ Time Frame: through day 108 ] [ Designated as safety issue: No ]Using the ELIspot assay, describe the frequency of immune responses among patients treated with anti-estrogen therapies
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: 9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, 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).
poly-ICLCBiological: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532960
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Patrick M Dillon, MD||University of Virginia|