A Pilot Study Of Sequential Vaccinations With Recombinant Vaccinia-CEA(6D)-TRICOM, And Recombinant Fowlpox-CEA(6D)-TRICOM (B7.1/ICIAM-1/LFA-3) With Sargramostim (GM-CSF), In Conjunction With Standard Adjuvant Chemotherapy In High Risk Breast Cancer Patients Status Post Surgery With 4+ Or More Lymph Nodes And CEA Expressing Tumors
- Compare the immunological effects of 2 different schedules of vaccinia-CEA-TRICOM
vaccine, fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF) administered with
standard adjuvant chemotherapy in women with high-risk stage II or III breast cancer.
- Compare the safety of these regimens in these patients.
- Determine the feasibility of obtaining determinations of CD4 response in patients
treated with these regimens.
- Compare disease-free survival of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Vaccinia-CEA-TRICOM: Beginning 2-3 weeks after surgery and before initiation of
standard adjuvant chemotherapy, all patients receive vaccinia-CEA-TRICOM vaccine
subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4 of week 1.
- Fowlpox-CEA-TRICOM: Patients are treated on 1 of the following schedules:
- Arm I: During chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day
1 and GM-CSF SC on days 1-4 of weeks 2, 5, 8, 11, 14, 17, 20, and 23. After
chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
- Arm II: Prior to chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on
day 1 and GM-CSF SC on days 1-4 of week 2. After chemotherapy, patients receive
additional vaccinations on weeks 26, 38, and 50.
- Chemotherapy: Patients receive doxorubicin IV over 5-7 minutes and cyclophosphamide IV
over 30 minutes on day 1 of weeks 3, 6, 9, and 12. Patients then receive paclitaxel IV
over 3 hours on day 1 of weeks 15, 18, 21, and 24. Treatment continues in the absence
of disease progression (after at least 1 course of chemotherapy) or unacceptable
- Radiotherapy: Patients undergo radiotherapy during weeks 26-32 in the absence of
Patients with hormone-receptor positive tumors receive oral tamoxifen for 5 years beginning
on approximately week 32.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 28 (14 per treatment arm) patients will be accrued for this
study within 18 months.
Allocation: Randomized, Primary Purpose: Treatment
Philip M. Arlen, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|Center for Cancer Research||Bethesda, Maryland 20892|