Direct Tumor Injection KLH-Pulsed Dendritic Cells in Unresectable Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00868114 |
Recruitment Status :
Terminated
(Poor recruitment)
First Posted : March 24, 2009
Last Update Posted : October 17, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Pancreatic Cancer | Biological: KLH-pulsed autologous dendritic cell vaccine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
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 |
- Overall Survival [ Time Frame: Patients will be followed until death ]

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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:
- 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
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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

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 ClinicalTrials.gov identifier (NCT number): NCT00868114
United States, North Carolina | |
East Carolina University - Leo W. Jenkins Cancer Center | |
Greenville, North Carolina, United States, 27834 |
Principal Investigator: | Emmanuel E Zervos, MD | East Carolina University - Leo W. Jenkins Cancer Center |
Responsible Party: | Leo W. Jenkins Cancer Center |
ClinicalTrials.gov Identifier: | NCT00868114 |
Other Study ID Numbers: |
LJCC 09-01 RCA115018B |
First Posted: | March 24, 2009 Key Record Dates |
Last Update Posted: | October 17, 2018 |
Last Verified: | October 2018 |
Inoperable pancreatic cancer Dendritic Cell Vaccine Locally advanced or low volume metatstatic pancreatic cancer |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |