Evaluation of Safety of Rexin-G Gene Transfer for Advanced Pancreatic Cancer

Inclusion Criteria:

* Age 18 years or older.
* Locally advanced or metastatic pancreatic cancer.
* Histologic or cytologic confirmation at diagnosis or recurrence of pancreatic cancer
* Measurable disease (RECIST) criteria. Tumor lesions that are situated in a previously irradiated area are not considered measurable, except if there is radiologically confirmed progression of disease within the radiation fields after radiation was completed.
* Failed gemcitabine chemotherapy as indicated by disease progression ≤ 6 months from last gemcitabine treatment
* Two or less than 2 chemotherapy regimens for recurrent/progressive disease.
* Adequate hepatic function based on laboratory values obtained less than 7 days prior to registration:

  * Total bilirubin \<2.0 mg/dL;
  * AST \< 2 x ULN;
  * AST \< 2 x ULN;
  * Hgb \> 9.0 gm/dL;
  * PT \< ULN;
  * PTT \<ULN;
  * Albumin \> 3.0 gm/dL;
  * Alkaline phosphatase \< 3 x ULN;
  * Absolute granulocyte count \> 1000/uL;
  * Platelet count \> 100,000/uL;
  * Serum creatinine \< 1.2 mg/dL for females; \< 1.4 mg/dL for males.
* ECOG performance status (PS) 0 or 1.
* Ability to provide informed consent.
* Life expectancy 12 weeks or greater.
* Male participants should be willing to provide semen samples at required intervals. Inability of the patient to provide all semen samples does not make the patient ineligible. (EXCEPTION: If the patient has been vasectomized. To be noted in the study file).
* Fertile patients agree to use barrier contraception (condoms plus spermicidal jelly) during the vector infusion period and for six weeks after infusion.
* Accessibility of peripheral or central IV line which is adequate for infusions of investigational agent.

Exclusion Criteria:

* Prior malignancy. (EXCEPTION: Patients who are disease free ≥ 5 years and/or patients with non-melanoma skin cancer, Stage I breast cancer, CIS of cervix)
* Any of the following:

  * Pregnant women;
  * Nursing women;
  * Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.). This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
* Patients who are HIV+, HBV+ or HCV+.
* Clinically significant ascites causing symptoms or requiring therapeutic paracentesis.
* Medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
* Concomitant use of other chemotherapeutic, viral or immunotherapeutic agents is not allowed during the 6-week study period.
* ≤ 4 weeks from radiation therapy of their pancreatic primary or ≤ 2 weeks from palliative radiation therapy to metastatic sites.
* ≤ 4 weeks from prior chemotherapy.
* History of congestive heart failure.