Combination of Chemotherapy With Taxol, Adriamycin, and Cytoxan (TAC), Multiple Infusions of Activated T Cells (ATC), Interleukin-2 (IL-2) and GM-CSF for High Risk Breast Cancer With and Without Her2/Neu Overexpression. (Phase I/II)
- Determine the toxic effects of sequential paclitaxel (or other taxane), doxorubicin,
and cyclophosphamide followed by immunotherapy with activated T cells, interleukin-2,
and sargramostim (GM-CSF) in patients with high-risk stage II or III breast cancer.
- Determine the disease-free survival and overall survival of patients treated with this
- Determine the immune function of patients treated with this regimen.
OUTLINE: Patients are stratified according to number of positive lymph nodes (less than 4
nodes vs 4-9 nodes vs 10 or more nodes), type of taxane chemotherapy during study
(paclitaxel vs other taxane), and prior treatment with 2 of 3 study chemotherapy agents (yes
Patients receive doxorubicin IV on day 1 and filgrastim (G-CSF) on days 3-10 of 3
consecutive 14-day courses. Patients then receive paclitaxel or another taxane IV on day 1
and G-CSF on days 3-10 of 3 consecutive 14-day courses. Patients then receive
cyclophosphamide IV on day 1 and G-CSF on days 3-10 of 3 consecutive 14-day courses.
Patients who enroll after previously receiving 2 of these 3 chemotherapy drugs may receive
the third. Treatment continues in the absence of disease progression or unacceptable
After recovery from chemotherapy, patients undergo peripheral blood mononuclear cell (PBMC)
collection. The PBMC are treated ex vivo with monoclonal antibody OKT3 to form activated T
cells (ATC). The ATC are expanded for up to 14 days in interleukin-2 (IL-2).
At 3-4 weeks after PBMC collection, patients receive ATC IV over 15-30 minutes weekly for 8
weeks. Patients also receive IL-2 subcutaneously (SC) daily and sargramostim (GM-CSF) SC
twice weekly beginning 3 days before the first ATC infusion and continuing until 7 days
after completion of ATC therapy.
Patients are followed every 3 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 40-60 patients will be accrued for this study within 4-5
Primary Purpose: Treatment
Lawrence G. Lum, MD, DSc
Roger Williams Medical Center
United States: Federal Government
|Roger Williams Medical Center||Providence, Rhode Island 02908-4735|