Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer
Primary Purpose
Metastatic Pancreatic Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
KLH-pulsed autologous dendritic cell vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Inoperable pancreatic cancer, Dendritic Cell Vaccine, Locally advanced or low volume metatstatic pancreatic cancer
Eligibility 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
Sites / Locations
- East Carolina University - Leo W. Jenkins Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
3 weekly injections of intratumoral TNFerade plus radiation and 3 weekly intratumoral injections of dendritic cell vaccine
Radiation Only with 3 weekly intratumoral injections of dendritic cell vaccine
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00868114
First Posted
March 23, 2009
Last Updated
October 15, 2018
Sponsor
Leo W. Jenkins Cancer Center
Collaborators
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00868114
Brief Title
Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leo W. Jenkins Cancer Center
Collaborators
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
Inoperable pancreatic cancer, Dendritic Cell Vaccine, Locally advanced or low volume metatstatic pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
3 weekly injections of intratumoral TNFerade plus radiation and 3 weekly intratumoral injections of dendritic cell vaccine
Arm Title
2
Arm Type
Experimental
Arm Description
Radiation Only with 3 weekly intratumoral injections of dendritic cell vaccine
Intervention Type
Biological
Intervention Name(s)
KLH-pulsed autologous dendritic cell vaccine
Intervention Description
5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
Patients will be followed until death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel E Zervos, MD
Organizational Affiliation
East Carolina University - Leo W. Jenkins Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University - Leo W. Jenkins Cancer Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer
We'll reach out to this number within 24 hrs