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 suspended participant recruitment.
(Closed to Accrual)
Sponsor:
Information provided by (Responsible Party):
Mark Zalupski, M.D., University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00843830
First received: February 12, 2009
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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
Biological: Additional cycles
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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:
  • To evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the anti-tumor response as determined by RECIST criteria [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: October 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm 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- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Biological: Additional cycles
Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 > 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 < 15, INR < 1.5 and PTT < 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, 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843830

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

No publications provided

Responsible Party: Mark Zalupski, M.D., Professor, Department of Internal Medicine, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00843830     History of Changes
Other Study ID Numbers: UMCC 2005.135
Study First Received: February 12, 2009
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Carcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 16, 2014