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

NCT00121745 | Terminated Phase 1 DMC

• 1 other identifier: MC044C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatic Cancer

Keywords

gene transfer; cell cycle control; cancer gene therapy; pathotropic targeting; tumor targeted retroviral vector

Outcome Measures

Primary Outcomes (1)

• To determine the dose limiting toxicity and maximum tolerated dose of Rexin-G administered as intravenous infusions; To evaluate pharmacokinetics of Rexin-G

  22 months

Secondary Outcomes (1)

• To assess anti-tumor activity of intravenously administered Rexin-G and obtain preliminary data on biochemical markers of tumor response

  22 months

Study Arms (4)

1

EXPERIMENTAL

Genetic: Rexin-G Dose 1

2

EXPERIMENTAL

Genetic: Rexin-G Dose 2

3

EXPERIMENTAL

Genetic: Rexin-G Dose 3

4

EXPERIMENTAL

Genetic: Rexin-G Dose 4

Interventions

Rexin-G Dose 1 GENETIC

Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose I 3- 6 Days 1-7, 15-21 7.5 x 10e9 cfu 500 ml

1

Rexin-G Dose 2 GENETIC

Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose II 3- 6 Days 1-7, 15-21 1.1 x 10e10 cfu 500 ml

2

Rexin-G Dose 3 GENETIC

Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose III 3- 6 5 days/wk x 4 wks 3.0 x 10e10 cfu 500 ml

3

Rexin-G Dose 4 GENETIC

Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose IV 3- 6 5 days/wk x 4 wks 8.0 x 10e10 cfu 500 ml

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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.

Sponsors & Collaborators

• Epeius Biotechnologies: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Evanthia Galanis, M.D.

  Mayo Clinic - Rochester, Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2005
• Study Completion: July 1, 2007
• Last Updated: December 20, 2007

Record last verified: 2007-12

Locations

US (1)