Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer

This is an interventional treatment trial for Neoplasms, Pancreas Read More

Inclusion Criteria:

• 1. Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas. The site of the primary lesion should be confirmed endoscopically, radiologically, or surgically to be in the pancreas.

  2. Patients must be deemed unresectable due to involvement of critical vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.

  3. Patients must have a primary or metastatic lesion measurable in at least one dimension by RECIST criteria within 4 weeks prior to entry of study .

  4. More than 4 weeks must have elapsed from the time of major surgery or completion of the last dose of chemotherapy, radiation therapy, investigational therapy and patients must adequately recover from these effects.

  5. Life expectancy of >3 months. 6. Karnofsky performance status >70%. 7. The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation):

• Hemoglobin: Within normal range according to institutional standards;
• Absolute leukocyte count: Within normal range according to institutional standards;
• Absolute lymphocyte count: Within normal range according to institutional standards;
• Platelet count: Within normal range according to institutional standards;
• Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN);
• Aspartate aminotransferase: ≤ 2.5 x ULN;
• Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN;
• Serum creatinine: 1.5 x ULN;
• Calculated creatinine clearance: > 50 mL/min . 8. Age >18 years. 9. No history of autoimmune diseases. 10. Ability to understand the study protocol and a willingness to sign a written informed consent document.

Exclusion Criteria:

- 1. Patients receiving anticoagulation therapy. 2. Patients who have received prior gemcitabine or radiation therapy to the pancreatic bed 3. Patients receiving any other investigational agents. 4. Patients with known brain metastases will be excluded because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse effects.

5. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.

6. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 7. level 3 hypertension; 8. severe coronary disease; 9. myelosuppression; 10. respiratory disease; 11. brain metastasis; 12. chronic infections