HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy

Breast Cancer Clinical Trial

— Neoadjuvant  

Official title:

Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer Post Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02061423
• Other study ID #: MCC-18776
• Secondary ID: UPCC26113
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 8, 2014
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02110199

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: December 2024
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women = 18 years.
• HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
• Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
• Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
• Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion Criteria:

• Pregnant or lactating.
• Positive for HIV or hepatitis C at baseline by self report.
• Potential participants with coagulopathies, including thrombocytopenia with platelet count <75,000, INR > 1.5 and partial thromboplastin time > 50 sec.
• Potential participants with MUGA < 50% EF.
• Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. doi: 10.1158/0008-5472.CAN-06-4038. Epub 2007 Feb 9. — View Citation

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. doi: 10.1158/0008-5472.CAN-07-0878. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation Compliance	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.	Up to 18 months
Primary	Occurrence of Treatment Related Adverse Events	Number of participants with treatment related adverse events, per event category.	Up to 18 months
Secondary	Immunogenicity	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.	Up to 5 years follow-up
Secondary	Anti-HER2 Immunity	Anti-HER2 response will be quantitated as EOS/baseline fold change in dilution studies.	Up to 5 years follow-up

External Links

•   Moffitt Cancer Center Clinical Trials website