Trial Information

An Open Label Randomized Trial Comparing the Safety and Efficacy of Systemic Chemotherapy (Gemcitabine) to Immunotherapy (CYTOIMPLANT - Intra Tumor Implants of Allogeneic Peripheral Blood Mononuclear Cells Sensitized Against Patient Alloantigens by Mixed Lymphocyte Culture) as First Line Therapy for Patients With Unresectable Locally Advanced, and Metastatic Pancreatic Cancer

OBJECTIVES: I. Compare the efficacy of CYTOIMPLANT (intratumor implants of allogeneic
peripheral blood mononuclear cells sensitized against patient alloantigens by mixed
lymphocyte culture) vs gemcitabine in patients with unresectable, locally advanced or
metastatic pancreatic cancer. II. Compare the overall survival, progression free survival,
objective tumor response, time to treatment failure, and quality of life of these patients.
III. Compare the safety and toxicities of CYTOIMPLANT vs gemcitabine in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are randomly assigned
(2:1 ratio in favor of CYTOIMPLANT arm) to one of two treatment arms. Arm I: Patients
receive gemcitabine IV weekly for 7 weeks, followed by 1 week of rest. In subsequent
courses, patients then receive gemcitabine IV weekly for 3 weeks followed by a week of rest.
Courses are repeated every 4 weeks in the absence of disease progression or unacceptable
toxicity. Arm II: Patients undergo leukapheresis to collect lymphocytes. Patient lymphocytes
are mixed with donor lymphocytes at the sponsor labs. The mixture is implanted into the
tumor using endoscopic ultrasound guided fine needle injection. This process may be repeated
in the fifth month using different donor's lymphocytes. Follow up assessments may include
physical exams, lab tests, CT scans, and quality of life assessments at 4 weeks and at 3, 5,
7, 9, and 12 months from the date of randomization. Patients are then contacted every 3
months to assess status.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.