search
Back to results

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

Primary Purpose

Metastatic Pancreatic Carcinoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tumoral irradiation
Dendritic cell vaccination
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Universtiy of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Participants will receive tumoral irradiation and dendritic cell vaccination.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Patients That Respond to Treatment
To evaluate the anti-tumor response as determined by RECIST criteria

Full Information

First Posted
February 12, 2009
Last Updated
November 6, 2015
Sponsor
University of Michigan Rogel Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00843830
Brief Title
A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Study closed early secondary to inability to obtain grant funding to conduct.
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Participants will receive tumoral irradiation and dendritic cell vaccination.
Intervention Type
Radiation
Intervention Name(s)
tumoral irradiation
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Dendritic cell vaccination
Intervention Description
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 Measure Information:
Title
The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination.
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Number of Patients That Respond to Treatment
Description
To evaluate the anti-tumor response as determined by RECIST criteria
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark M. Zalupski, M.D.
Organizational Affiliation
Universtiy of Michigan Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtiy of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs