A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
- 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
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
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 18-24
Primary Purpose: Treatment
Clinical response (patients with evaluable disease)
Charles L. Wiseman, MD, FACP
United States: Federal Government
|St. Vincent Medical Center - Los Angeles||Los Angeles, California 90057|