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

Stopped early · Phase 1

Conditions studied: Pancreatic Cancer

In brief

This is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Rexin-G is a tumor-targeted gene therapy vector that contains a "killer" gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle control element that plays an important role in cancer growth. When injected into a vein, the Rexin-GTM vector seeks out and accumulates in cancerous tumors, therefore, increasing the concentration of the drug in the cancerous tumors and not in normal neighbouring organs.

Key facts

Study ID: NCT00121745
Run by: Epeius Biotechnologies
People needed: 12
Starts: 2005-07-01
Expected to finish: 2007-07-01
Last updated by the study team: 2007-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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