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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

Phase 2
18 Years
Open (Enrolling)
Metastatic Pancreatic Cancer

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Patients will be followed until death

Safety Issue:


Principal Investigator

Emmanuel E Zervos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

East Carolina University - Leo W. Jenkins Cancer Center


United States: Food and Drug Administration

Study ID:

LJCC 09-01



Start Date:

July 2006

Completion Date:

Related Keywords:

  • Metastatic Pancreatic Cancer
  • Inoperable pancreatic cancer
  • Dendritic Cell Vaccine
  • Locally advanced or low volume metatstatic pancreatic cancer
  • Pancreatic Neoplasms



East Carolina University - Leo W. Jenkins Cancer CenterGreenville, North Carolina  27834