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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843830
Recruitment Status : Terminated (Study closed early secondary to inability to obtain grant funding to conduct.)
First Posted : February 13, 2009
Results First Posted : November 5, 2014
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Carcinoma Radiation: tumoral irradiation Biological: Dendritic cell vaccination Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

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 :
  1. 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 :
  1. Number of Patients That Respond to Treatment [ Time Frame: 10 weeks ]
    To evaluate the anti-tumor response as determined by RECIST criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843830

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United States, Michigan
Universtiy of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
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Principal Investigator: Mark M. Zalupski, M.D. Universtiy of Michigan Comprehensive Cancer Center
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Responsible Party: University of Michigan Rogel Cancer Center Identifier: NCT00843830    
Other Study ID Numbers: UMCC 2005.135
First Posted: February 13, 2009    Key Record Dates
Results First Posted: November 5, 2014
Last Update Posted: December 8, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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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