HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy
Study Details
Study Description
Brief Summary
The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: HER-2 Pulsed Dendritic Cell Vaccine 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. |
Biological: HER-2 pulsed Dendritic Cell Vaccine
Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
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Outcome Measures
Primary Outcome Measures
- Participation Compliance [Up to 18 months]
Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (6 weekly vaccinations). Data collection will include rate of successful completion and occurrence rate for each reason stated for non-completion.
- Occurrence of Treatment Related Adverse Events [Up to 18 months]
Number of participants with treatment related adverse events, per event category.
Secondary Outcome Measures
- Immunogenicity [Up to 5 years follow-up]
Immunogenicity will be evaluated by descriptive statistics, plots of pre- and post-treatment values and fold changes. Immune response rate and 95% exact confidence interval will be calculated.
- Anti-HER2 Immunity [Up to 5 years follow-up]
Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women ≥ 18 years.
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HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
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Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
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Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
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Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
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Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Exclusion Criteria:
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Pregnant or lactating.
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Positive for HIV or hepatitis C at baseline by self report.
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Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
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Potential participants with MUGA < 50% EF.
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Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
2 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
Investigators
- Principal Investigator: Brian Czerniecki, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Czerniecki BJ, Koski GK, Koldovsky U, Xu S, Cohen PA, Mick R, Nisenbaum H, Pasha T, Xu M, Fox KR, Weinstein S, Orel SG, Vonderheide R, Coukos G, DeMichele A, Araujo L, Spitz FR, Rosen M, Levine BL, June C, Zhang PJ. Targeting HER-2/neu in early breast cancer development using dendritic cells with staged interleukin-12 burst secretion. Cancer Res. 2007 Feb 15;67(4):1842-52. Epub 2007 Feb 9.
- Czerniecki BJ, Roses RE, Koski GK. Development of vaccines for high-risk ductal carcinoma in situ of the breast. Cancer Res. 2007 Jul 15;67(14):6531-4. Review.
- Koski GK, Koldovsky U, Xu S, Mick R, Sharma A, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Czerniecki BJ. A novel dendritic cell-based immunization approach for the induction of durable Th1-polarized anti-HER-2/neu responses in women with early breast cancer. J Immunother. 2012 Jan;35(1):54-65. doi: 10.1097/CJI.0b013e318235f512.
- Sharma A, Koldovsky U, Xu S, Mick R, Roses R, Fitzpatrick E, Weinstein S, Nisenbaum H, Levine BL, Fox K, Zhang P, Koski G, Czerniecki BJ. HER-2 pulsed dendritic cell vaccine can eliminate HER-2 expression and impact ductal carcinoma in situ. Cancer. 2012 Sep 1;118(17):4354-62. doi: 10.1002/cncr.26734. Epub 2012 Jan 17.
- MCC-18776
- UPCC26113
- NCT02110199