Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Leo W. Jenkins Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by:
Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:
NCT00868114
First received: March 23, 2009
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

This research study uses radiation or a gene therapy agent, TNFerade in addition to a dendritic cell vaccine in patients with locally advanced or low volume metastatic pancreatic cancer. The use of TNFerade or radiation serves to generate cell death stimulating the immune response. The dendritic cell vaccine may direct a distant and lasting effective anti-tumor immune response to achieve a local and systemic clinical benefit.


Condition Intervention Phase
Metastatic Pancreatic Cancer
Biological: KLH-pulsed autologous dendritic cell vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Apoptosis Induction Through Direct Tumor Injection of TNFerade(TM)or Radiation Alone Followed by KLH-Pulsed Autologous Dendritic Cells in Patients With Unresectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Leo W. Jenkins Cancer Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Patients will be followed until death ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2006
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
3 weekly injections of intratumoral TNFerade plus radiation and 3 weekly intratumoral injections of dendritic cell vaccine
Biological: KLH-pulsed autologous dendritic cell vaccine
5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks
Experimental: 2
Radiation Only with 3 weekly intratumoral injections of dendritic cell vaccine
Biological: KLH-pulsed autologous dendritic cell vaccine
5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven, unresectable pancreatic cancer with an intact primary tumor that is accessible to direct intratumoral injection
  • Low volume metastatic disease defined as 1) radiographically occult disease discovered at the time of anticipated resection or 2) no more than 4 radiographically detected metastasis none of which are greater than 2 cm in greatest dimension
  • Good overall health with a Karnofsky performance status of 70% or greater
  • No evidence or history of an autoimmune dysfunction
  • Life expectancy > 3 months
  • Agreement to initiate and complete standard treatment (chemotherapy ± radiation) for pancreatic cancer at the completion of the study
  • Age equal to or greater than 18 years
  • No prior or concurrent chemotherapy
  • No previous or concurrent immunotherapy for pancreatic cancer
  • Liver enzymes ≤ 3 times upper limit of normal:
  • Tbili ≤ 3.9 (biliary stents are allowed)
  • AST ≤ 177
  • ALT ≤ 198
  • Alk phos ≤ 378
  • Adequate pretreatment organ function:

    • Creatinine no greater than 1.5mg/dL
    • Total calcium no greater than 11.0mg/dL
    • PT no greater then 14 seconds
    • PTT no greater then 40 seconds
  • Ability to give informed consent
  • Adequate baseline hematopoietic function:

    • Total white blood cell count equal to or greater than 3,000/mm3;
    • Absolute granulocyte count greater than 1,500/mm3;
    • Absolute lymphocyte count greater than 500/mm3;
    • Platelet count equal to or greater than 100,000/mm3.

Exclusion Criteria:

  • Prior history of XRT to primary pancreatic tumor
  • Patients with tumors that are not accessible to direct access cannot be included in the study, nor will patients with poor overall health as determined by standard laboratory data and performance scales
  • Prior or concurrent chemotherapy
  • Prior history (within last four weeks) of antineoplastic therapy or irradiation
  • Prior treatment with anti-tumor vaccines not allowed
  • Patients with a history of autoimmune diseases such as SLE, rheumatoid arthritis or myasthenia gravis
  • A history of HIV infection, AIDS or other immunosuppressive disease state
  • Patients requiring regular corticosteroids within the past year are ineligible. There must be no use of corticosteroids in the fours weeks preceding entry into the study
  • Active bacterial, fungal or viral infection
  • Active bleeding (hemoptysis, melena, etc)
  • Women who are currently pregnant or actively breast feeding. Women of childbearing potential must have a negative serum pregnancy test and must use effective contraception during trial participation
  • Uncontrolled or unstable medical conditions, including angina, bronchospasm, hypertension, hyperglycemia, hypercalcemia and cardiac arrhythmia
  • Any medical or psychiatric illness which in the opinion of the principal investigator might compromise a patient's ability to tolerate or complete treatment
  • Patients requiring anticoagulation are ineligible
  • Refusal to receive standard treatment (chemotherapy ± radiation) after the completion of the protocol
  • Evidence of DVT or prior history of DVT
  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: NCT00868114

Locations
United States, North Carolina
East Carolina University - Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
Leo W. Jenkins Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Emmanuel E Zervos, MD East Carolina University - Leo W. Jenkins Cancer Center
  More Information

No publications provided

Responsible Party: Emmanuel Zervos, MD, East Carolina University Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier: NCT00868114     History of Changes
Other Study ID Numbers: LJCC 09-01, RCA115018B
Study First Received: March 23, 2009
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Leo W. Jenkins Cancer Center:
Inoperable pancreatic cancer
Dendritic Cell Vaccine
Locally advanced or low volume metatstatic pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014