Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41)
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|ClinicalTrials.gov Identifier: NCT01532960|
Recruitment Status : Terminated (Futility for immune responses to the vaccine. Also, a component of study drug was in short supply.)
First Posted : February 15, 2012
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: poly-ICLC Biological: 9 Peptides from Her-2/neu, CEA, & CTA Biological: Peptide-tet||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage I-IV Breast Cancer|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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).
Biological: 9 Peptides from Her-2/neu, CEA, & CTA
9 synthetic peptides derived from Her-2/neu, CEA & CTA derived breast cancer proteins.
A class II MHC-restricted helper peptide derived from tetanus toxoid protein.
- Safety (Frequency of dose limiting adverse events) [ Time Frame: 30 days post-administration of the last vaccine ]
- Immune response rate [ Time Frame: through day 108 ]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 ]
- Immunogenicity- CD8+ T cell specificity [ Time Frame: through day 108 ]Characterize vaccine specific peripheral CD8+ T-cell specificity by tetramer staining and flow cytometric analysis
- Immunogenicity- CD8+ cytokine production [ Time Frame: 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 [ Time Frame: through day 108 ]Using the ELIspot assay, describe the frequency of immune responses among patients treated with anti-estrogen therapies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532960
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Patrick M Dillon, MD||University of Virginia|