Pancreatic Cancer Clinical Trial
Official title:
A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE
RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the
body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy
use different ways to stop tumor cells from dividing so they stop growing or die.
Colony-stimulating factors may help a person's immune system recover from the side effects
of chemotherapy. Combining these treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using
donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide
plus GM-CSF in treating patients with advanced pancreatic cancer.
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.
;
Primary Purpose: Treatment
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