A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
18 Years
N/A
Both
Breast Cancer
Trial Information
A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
OBJECTIVES:
Primary
- To establish the safety of HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine when administered via 3 different routes in patients with ductal carcinoma in
situ of the breast.
- To establish the immune response rate in patients treated with this vaccine.
Secondary
- To evaluate changes in HER2/neu molecular expression pre- and post-vaccination.
- To evaluate the clinical response pre-and post-vaccination.
- To conduct exploratory analyses of possible relationships among these outcomes.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Patients undergo leukapheresis to obtain monocyte fractions for generation of the vaccine.
The monocytes are cultured with GM-CSF, interleukin-4, interferon gamma, and
lipopolysaccharide and pulsed with HER2/neu peptides for the production of type 1 dendritic
cells.
- Arm I: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once
weekly for 6 weeks.
- Arm II: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine intralesionally into the quadrant of the affected breast once weekly for 6
weeks.
- Arm III: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell
vaccine intranodally and intralesionally as in arms I and II.
Within 2-3 weeks after the completion of the last vaccination, patients undergo complete
surgical excision (wide excision or mastectomy to negative margins) of their tumor.
After completion of study treatment, patients are followed up every 6 months for 5 years and
then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS)
- DCIS with evidence of microinvasion allowed
- HER2/neu-positive tumor, as defined by > 5% of tumor cells staining ≥ 2+ by Hercept
(Dako) antibody testing
- No evidence of invasive breast cancer by MRI performed within the past 2 months
- Hormone-receptor status:
- Not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Ejection fraction ≥ 50% by MUGA
- No major cardiac illness
- No coagulopathies, including any of the following:
- Thrombocytopenia with platelet count < 75,000/mm^3
- INR > 1.5
- PTT > 50 sec
- No laboratory tests (including CBC, liver function tests, urinalysis, and EKG)
reflecting > grade 1 toxicity, as assessed by NCI CTC v3.0, that cannot be corrected
on repeat testing within 7 days
- No HIV or hepatitis C positivity
- No other pre-existing medical illness that may interfere with study participation
PRIOR CONCURRENT THERAPY:
- No prior definitive treatment for DCIS
- No prior complete excisional biopsy of the tumor
- No concurrent medications that may interfere with study participation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Safety as assessed by NCI CTC v3.0
Safety Issue:
Yes
Principal Investigator
Brian J. Czerniecki, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
Unspecified
Study ID:
CDR0000644921
NCT ID:
NCT00923143
Start Date:
March 2009
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- HER2-positive breast cancer
- male breast cancer
- Breast Neoplasms
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
