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

NCT02061423 | Completed Phase 1 FDA Drug

• 2 other identifiers: MCC-18776UPCC26113
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Invasive Breast Cancer; Breast Cancer; Immunotherapy; Vaccine; Dendritic Cell; Neoadjuvant

Outcome Measures

Primary Outcomes (2)

• 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

• Occurrence of Treatment Related Adverse Events

  Number of participants with treatment related adverse events, per event category.

  Up to 18 months

Secondary Outcomes (2)

• Immunogenicity

  Up to 5 years follow-up

• Anti-HER2 Immunity

  Up to 5 years follow-up

Study Arms (1)

HER-2 Pulsed Dendritic Cell Vaccine

EXPERIMENTAL

6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months.

Biological: HER-2 pulsed Dendritic Cell Vaccine

Interventions

HER-2 pulsed Dendritic Cell Vaccine BIOLOGICAL

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.

HER-2 Pulsed Dendritic Cell Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 17638860 BACKGROUND

• 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.

  PMID: 17293384 BACKGROUND

• 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.

  PMID: 22130160 BACKGROUND

• 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.

  PMID: 22252842 BACKGROUND

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brian Czerniecki, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 12, 2014
• Study Start: April 8, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 21, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

US (2)