A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
Condition: Metastatic Pancreatic Carcinoma
MeSH terms: Carcinoma; Pancreatic Neoplasms
Intervention: tumoral irradiation; Dendritic cell vaccination
Intervention description: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4); Three intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to determine whether it is possible to use an investigational
      vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells
      are immune cells that are obtained from your blood that are important in the body's immune
      response to foreign substances. The vaccine would be injected directly into a tumor that has
      spread to the liver after a short course of radiation therapy has been given to that tumor.
      The study will try to determine if this treatment would be safe and effective in treating
      this cancer.

      This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a
      treatment where little is known about its possible risks or benefits. Phase 2 studies then
      test the possible benefits of a treatment and may show the specific situations where they are
      seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment
      to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a
      treatment after it has been approved for general use outside of research. A pilot study tests
      a treatment in a small number of patients to learn if and how the treatment could be tested
      in a larger group. Pilot studies can be performed at any phase but are commonly performed in
      the earliest phases of research on a treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of pancreatic carcinoma

          -  Radiologic evidence of hepatic metastasis with at least one lesion > 2.0 cm that is
             amenable to ultrasound or CT guided intra-tumoral DC injection

          -  Age > 18

          -  Life expectancy > 3 months

          -  Karnofsky Performance Status > 70%

          -  Patients must not have received any anti-neoplastic chemotherapy, immunotherapy or
             radiotherapy for the four weeks preceding entry onto the study (six weeks for
             nitrosoureas and mitomycin C).

          -  Adequate baseline hematopoietic function defined as WBC (white blood cell) > 3000/mm3,
             hemoglobin > 9g/dl, and platelet count > 100,000/mm3.

          -  Adequate baseline organ function defined as creatinine < 2.0, total bilirubin < 2.0
             mg/dl

          -  Patients taking warfarin are not eligible. Adequate coagulation function defined as PT
             (prothrombin time) < 15, INR < 1.5 and PTT (partial thromboplastin time) < 35.

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Previous anti-tumor vaccine therapy

          -  Prior hepatic irradiation

          -  Known brain metastases

          -  History of prior autoimmune diseases (e.g. SLE (systemic lupus erythematosus),
             rheumatoid arthritis, myasthenia gravis)

          -  Regular corticosteroid use within the past one year or any corticosteroid use in the
             four weeks preceding study entry

          -  Evidence of HIV infection, AIDS, Hepatitis B or Hepatitis C infection

          -  Active bacterial, fungal or viral infection

          -  Pregnancy or lactation; women of childbearing potential and men must agree to use
             effective contraception during the course of this clinical trial

          -  Uncontrolled or unstable medical conditions including angina, arrhythmias, bleeding,
             or thromboembolic conditions,

          -  Any medical or psychiatric illness that might compromise the patients ability to
             tolerate treatment