Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41)
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.
|Study Design:||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 IB-IIIA Breast Cancer|
- Frequency of dose limiting adverse events. [ Designated as safety issue: Yes ]
- Immune response rate as measured by the number of IFN-gamma producing cells/well in a direct ELIspot assay of PBMCs collected at 30 days from the last peptide + poly-ICLC vaccination. [ Designated as safety issue: No ]
- The number of serious adverse events from the time of enrollment as defined by CTCAEv4.03 [ Designated as safety issue: Yes ]
- Characterize responding peripheral CD8+ T-cell specificity by tetramer staining and measure by standardized flow cytometric criteria at 30 days post vaccine. [ Designated as safety issue: No ]
- The CD8+ T-cell activation as measured by cytokine bead assay upon peptide stimulation at 30 days from last vaccine. [ Time Frame: 30 days from last vaccine ] [ Designated as safety issue: No ]
- The frequency of immune responses among patients treated with anti-estrogen therapies [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Biological: 9 Peptides from Her-2/neu, CEA, & CTA + poly-ICLC
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
|Contact: Emily Allred, PhD||434-982-1902||EH4M@virginia.edu|
|Contact: Kristy Scottemail@example.com|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Emily Allred, PhD 434-982-1902 EH4M@hscmail.mcc.virginia.edu|
|Principal Investigator:||Patrick M Dillon, MD||University of Virginia|