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Brief Title: Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma
Official Title: Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemotherapy for the Adjuvant Treatment of Pancreatic Adenocarcinoma (DECIST)
Study ID: NCT04157127
Brief Summary: This is a phase 1, first in man, dose escalation study for safety and feasibility for administration of 3 doses of DC vaccine for pancreatic adenocarcinoma.
Detailed Description: The primary objective of this phase 1, first in man trial is to determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with pancreatic adenocarcinoma lysate plus mRNA to pancreatic cancer patients as adjuvant therapy following completion of standard chemotherapy. Patients will first complete standard treatment for pancreatic adenocarcinoma which is surgically resectable or potentially resectable and then within 3 months of finishing standard treatment, they will have three doses of the dendritic cell vaccine by perinodal injection using ultrasound (US) or computed-tomography (CT) guidance.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Baylor College of Medicine Medical Center - McNair Campus, Houston, Texas, United States
Baylor St. Lukes Medical Center, Houston, Texas, United States
Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston, Texas, United States
Name: Benjamin Musher, MD
Affiliation: Baylor College of Medicine
Role: PRINCIPAL_INVESTIGATOR