Status:
TERMINATED
Evaluation of Safety of Rexin-G Gene Transfer for Advanced Pancreatic Cancer
Lead Sponsor:
Epeius Biotechnologies
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 chemother...
Detailed Description
Pancreatic cancer is the fourth leading cause of cancer death in the United States. Every year, about 30,000 new patients are diagnosed with pancreatic cancer, and most will die within the year. The f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00121745
Start Date
July 1 2005
End Date
July 1 2007
Last Update
December 20 2007
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905