NCT00843830

A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine whether it is possible to use an investigational vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells are immune cells that are obtained from your blood that are important in the body's immune response to foreign substances. The vaccine would be injected directly into a tumor that has spread to the liver after a short course of radiation therapy has been given to that tumor. The study will try to determine if this treatment would be safe and effective in treating this cancer. This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a treatment where little is known about its possible risks or benefits. Phase 2 studies then test the possible benefits of a treatment and may show the specific situations where they are seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a treatment after it has been approved for general use outside of research. A pilot study tests a treatment in a small number of patients to learn if and how the treatment could be tested in a larger group. Pilot studies can be performed at any phase but are commonly performed in the earliest phases of research on a treatment.

Conditions

• Metastatic Pancreatic Carcinoma

Interventions

Type	Name	Description
RADIATION	tumoral irradiation	On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
BIOLOGICAL	Dendritic cell vaccination	Three intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• Completion: 2010-04-01
• First posted: 2009-02-13
• Last updated: 2015-12-08
• Results posted: 2014-11-05

Locations

1 site across 1 country: United States