Trial Information

A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE

OBJECTIVES: I. Determine the feasibility, toxicity, and antitumor effects of active specific
intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon
alfa plus low-dose adjuvant systemic sargramostim (GM-CSF) and cyclophosphamide in patients
with incurable pancreatic adenocarcinoma. II. Assess the immunologic and biologic correlates
of this treatment regimen in these patients.

OUTLINE: Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for
72-96 hours. Autologous cell lines, if established, may be used as an alternative. The cells
are irradiated immediately prior to use. Patients receive cyclophosphamide IV on day -3 and
sargramostim (GM-CSF) subcutaneously on days 0-8. On day 0, patients receive viable tumor
cells via dorsal pedal lymphatic cannulation. Treatment repeats every 2-4 weeks for a
minimum of 8 weeks in the absence of disease progression or unacceptable toxicity. Patients
are followed every 2-4 months.

PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.