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

Study Overview

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

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.

N/A

Metastatic Pancreatic Carcinoma

RADIATION: tumoral irradiation
BIOLOGICAL: Dendritic cell vaccination

UMCC 2005.135

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-02-12	Results First Submitted 2014-10-29	Last Update Submitted that met QC Criteria 2015-11-06
First Submitted that Met QC Criteria 2009-02-12	Results First Submitted that Met QC Criteria 2014-10-29	Last Update Posted (ESTIMATED) 2015-12-08
First Posted (ESTIMATED) 2009-02-13	Results First Posted 2014-11-05	Last Verified 2015-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment Arm Participants will receive tumoral irradiation and dendritic cell vaccination.	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment Arm

Participants will receive tumoral irradiation and dendritic cell vaccination.

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.

Primary Outcome Measures	Measure Description	Time Frame
The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.	The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.	10 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Number of Patients That Respond to Treatment	To evaluate the anti-tumor response as determined by RECIST criteria	10 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pathologic diagnosis of pancreatic carcinoma
Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is amenable to ultrasound or CT guided intra-tumoral DC injection
Age > 18
Life expectancy > 3 months
Karnofsky Performance Status > 70%
Patients must not have received any anti-neoplastic chemotherapy, immunotherapy or radiotherapy for the four weeks preceding entry onto the study (six weeks for nitrosoureas and mitomycin C).
Adequate baseline hematopoietic function defined as WBC (white blood cell) > 3000/mm3, hemoglobin > 9g/dl, and platelet count > 100,000/mm3.
Adequate baseline organ function defined as creatinine < 2.0, total bilirubin < 2.0 mg/dl
Patients taking warfarin are not eligible. Adequate coagulation function defined as PT (prothrombin time) < 15, INR < 1.5 and PTT (partial thromboplastin time) < 35.
Ability to give informed consent

Previous anti-tumor vaccine therapy
Prior hepatic irradiation
Known brain metastases
History of prior autoimmune diseases (e.g. SLE (systemic lupus erythematosus), rheumatoid arthritis, myasthenia gravis)
Regular corticosteroid use within the past one year or any corticosteroid use in the four weeks preceding study entry
Evidence of HIV infection, AIDS, Hepatitis B or Hepatitis C infection
Active bacterial, fungal or viral infection
Pregnancy or lactation; women of childbearing potential and men must agree to use effective contraception during the course of this clinical trial
Uncontrolled or unstable medical conditions including angina, arrhythmias, bleeding, or thromboembolic conditions,
Any medical or psychiatric illness that might compromise the patients ability to tolerate treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Mark M. Zalupski, M.D., Universtiy of Michigan Comprehensive Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record