Breast Cancer Clinical Trial
Official title:
A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make
the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine
therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide with tumor
cell vaccine in treating patients who have metastatic cancer or cancer at high risk of
recurrence.
OBJECTIVES:
- Determine the safety and clinical effects of autologous or allogeneic active-specific
intralymphatic immunotherapy with a vaccine containing interferon alfa or interferon
gamma-treated tumor cells followed by sargramostim (GM-CSF) in patients with advanced
cancer.
OUTLINE: This is a pilot study. Patients are stratified by tumor type.
Tumor tissue is removed from the patient and incubated with interferon alfa or interferon
gamma for 72-96 hours. (If autologous tumor cells are not available, an allogeneic vaccine
is prepared.) Harvested activated cells are irradiated immediately prior to use.
Patients receive cyclophosphamide IV. 48-72 hours after cyclophosphamide administration,
patients receive tumor cell vaccine intradermally. Patients also receive sargramostim
(GM-CSF) subcutaneously prior to vaccine administration and once daily for the next 8 days.
Treatment repeats every 2 weeks for 3 courses in the absence of unacceptable toxicity.
Patients with responding or stable disease after completion of course 3 may receive
additional courses.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 18-24
months.
;
Primary Purpose: Treatment
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