Metastatic Pancreatic CancerPhase 2NCT00868114
Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer
A Phase 2 study testing KLH-pulsed autologous dendritic cell vaccine in people with Metastatic Pancreatic Cancer, run by Leo W. Jenkins Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- KLH-pulsed autologous dendritic cell vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University - Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
About this study
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
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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- KLH-pulsed autologous dendritic cell vaccine
- Keywords
- Inoperable pancreatic cancer, Dendritic Cell Vaccine, Locally advanced or low volume metatstatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KLH-pulsed autologous dendritic cell vaccineBiological
5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 weekly injections of intratumoral TNFerade plus radiation and 3 weekly intratumoral injections of dendritic cell vaccine Receives: Biological: KLH-pulsed autologous dendritic cell vaccine |
| 2 | Experimental | Radiation Only with 3 weekly intratumoral injections of dendritic cell vaccine Receives: Biological: KLH-pulsed autologous dendritic cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Patients will be followed until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2013
- Study completionDec 2015
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leo W. Jenkins Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
- Investigators
- Emmanuel E Zervos, MD, Principal investigator, East Carolina University - Leo W. Jenkins Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868114
- Sponsor's protocol ID
- LJCC 09-01
- Other IDs
- RCA115018B
- Status last verified
- Oct 2018
- First submitted
- 23 Mar 2009
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00868114
- Acronym / sponsor ID
- LJCC 09-01
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Inoperable pancreatic cancer, Dendritic Cell Vaccine, Locally advanced or low volume metatstatic pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Leo W. Jenkins Cancer CenterUniversity, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- Study start
- Jul 2006
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: KLH-pulsed autologous dendritic cell vaccine3 weekly injections of intratumoral TNFerade plus radiation and 3 weekly intratumoral injections of dendritic cell vaccine |
| 2 | Experimental | Biological: KLH-pulsed autologous dendritic cell vaccineRadiation Only with 3 weekly intratumoral injections of dendritic cell vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KLH-pulsed autologous dendritic cell vaccine5 X10e7 KLH-pulsed autologous dendritic cell vaccine once weekly times three weeks | Biological | 1, 2 |
Primary outcome
Overall Survival
Time frame: Patients will be followed until death
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel E Zervos, MD principal investigator
East Carolina University - Leo W. Jenkins Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KLH-pulsed autologous dendritic cell vaccine in people with Metastatic Pancreatic Cancer, run by Leo W. Jenkins Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Patients will be followed until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.