Description:
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1
vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will
have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without
trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,
laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine
administration.
Title
- Brief Title: HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
- Official Title: Pilot Phase I HER-2 Pulsed DC Vaccine to Prevent Recurrence for Patients With HER-2 Driven High Risk Invasive Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
MCC-18777
- SECONDARY ID:
25113
- NCT ID:
NCT02063724
- NCT ALIAS:
NCT02110173
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| HER-2 pulsed Dendritic Cell Vaccine | | HER-2 Pulsed Dendritic Cell Vaccine |
Purpose
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1
vaccine in high risk HER-2 high and intermediate expression breast cancers. Participants will
have HER-2 driven IBC at least Stage IIIA with N2 following chemotherapy with/without
trastuzumab or recurrence exclusive of new primary tumor but rendered NED. Mammogram,
laboratory studies, CT, and leukapheresis will be performed, in addition to vaccine
administration.
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. Participants with
HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with
or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered
NED will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be
manufactured using participants' leukapheresis product, which will be administered in the
Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three booster vaccines will be
administered at 3 month intervals following the initial induction vaccines. Immune analysis
will be done after participant receives all induction vaccines and again after they receive
all booster vaccines.
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| HER-2 Pulsed Dendritic Cell Vaccine | Experimental | 6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. 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
Inclusion Criteria:
- Women over Age 18 years.
- Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than
or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered
NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+
FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1
year from their last treatment and have no evidence of disease.
- Deemed to require anti-estrogen therapy for treatment of their breast cancer can
continue anti-estrogen therapy during vaccinations.
- Women of childbearing age with a negative pregnancy test documented prior to
enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Willing to use birth control if necessary.
- 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 positive HIV or hepatitis C at baseline.
- Patients with coagulopathies, including thrombocytopenia with platelet count less than
75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
- Major cardiac illness MUGA less than 50% EF.
- Pre-existing medical illnesses or medications which might interfere with the study as
determined by Principal Investigator (PI).
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Rate of Treatment Regimen Completion |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | Number of participants willing and able to complete treatment regimen, to address feasibility. |
Secondary Outcome Measures
| Measure: | Immune Response |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | Number of participants with immune response. Participants will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing. |
| Measure: | Occurrence of Treatment Related Adverse Events |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Adverse Events reported as Related to Study Treatment, per adverse event category. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Trial Keywords
- Invasive Breast Cancer
- Breast Cancer
- Immunotherapy
- Vaccine
- Dendritic Cell
Last Updated
February 11, 2021
