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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 has been terminated.
(Study closed early secondary to inability to obtain grant funding to conduct.)
Information provided by (Responsible Party):
University of Michigan Cancer Center Identifier:
First received: February 12, 2009
Last updated: November 6, 2015
Last verified: November 2015

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.

Condition Intervention Phase
Metastatic Pancreatic Carcinoma
Radiation: tumoral irradiation
Biological: Dendritic cell vaccination
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Michigan Cancer Center:

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. [ Time Frame: 10 weeks ]
    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 [ Time Frame: 10 weeks ]
    To evaluate the anti-tumor response as determined by RECIST criteria

Enrollment: 4
Study Start Date: October 2006
Study Completion Date: April 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00843830

United States, Michigan
Universtiy of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Principal Investigator: Mark M. Zalupski, M.D. Universtiy of Michigan Comprehensive Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center Identifier: NCT00843830     History of Changes
Other Study ID Numbers: UMCC 2005.135
Study First Received: February 12, 2009
Results First Received: October 29, 2014
Last Updated: November 6, 2015

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 24, 2017