MedTrace Logo

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

NCT00843830 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-12-08

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Mark M. Zalupski, M.D. · Universtiy of Michigan Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-12-31
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843830 on ClinicalTrials.gov