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Safety/Efficacy Study of Rexin-G to Treat Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
Epeius Biotechnologies
ClinicalTrials.gov Identifier:
NCT00504998
First received: July 18, 2007
Last updated: June 9, 2011
Last verified: February 2010
History of Changes
  Purpose

The goal of the adaptive trial design is to determine the over-all safety of escalating doses of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.


Condition Intervention Phase
Pancreatic Cancer
 Genetic: Rexin-G
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic Pancreatic Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Epeius Biotechnologies:

Primary Outcome Measures:
  • Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles. [ Time Frame: 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To identify an objective tumor response to Rexin-G [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose Level 1 of escalating doses of Rexin-G i.v.
 Genetic: Rexin-G
Dosing Schedule: 1 x 10e11 cfu 2 times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Experimental: 2
Dose Level 2 of escalating doses of Rexin-G i.v.
 Genetic: Rexin-G
Dosing Schedule: 1 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Experimental: 3
Dose Level 3 of escalating doses of Rexin-G i.v.
 Genetic: Rexin-G
Dosing Schedule: 2 x 10e11 cfu three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.
Experimental: 4
Dose Level 4 of escalating doses of Rexin-G i.v.
 Genetic: Rexin-G
Dose Schedule: 3 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has less than Grade 1 or less toxicity.
Experimental: 5
Dose Level 5 of escalating doses of Rexin-G i.v.
 Genetic: Rexin-G
Dosing Schedule: 4 x 10e11 cfu i.v. three times a week for 4 weeks, followed by a 2-week rest period. Treatment cycle may be repeated if patient has Grade 1 or less toxicity.

Detailed Description:

The clinical trial is a safety and efficacy study using escalating doses of Rexin-G that incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted genetic medicine to catch up with tumor growth, halt disease progression, and reduce tumor burden. The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II/III pivotal trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically confirmed recurrent or metastatic pancreatic cancer that has failed gemcitabine and that is measurable.
  2. Adequate hepatic function: Total bilirubin < 2.0 mg/dL (upper limit included); AST/ALT < 2x institutional norm; alkaline phosphatase < 2.5x upper limit of institutional norm unless the patient has extensive bone metastases. Patients with elevated alkaline phosphatase due to extensive liver disease will be excluded from study; albumin > 3.0 mg/dL. There must be no substantial ascites. PT and PTT must be within normal limits.
  3. Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.
  4. Hemoglobin > 9 gms%
  5. Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.
  6. Serum creatinine of less than 1.5 mg%.
  7. There must be no plans for the patient to receive further cancer therapy from the date of enrollment until the completion of the 6-week follow-up visit.
  8. Accessibility of peripheral or central IV line
  9. Age > 10 years
  10. Patients will be off chemotherapy for a minimum of 4 weeks prior to initiation of therapy and should have recovered to Grade 1 or less toxicity.
  11. The ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Prior malignancy, except for non-melanoma skin cancer, stage 1 breast cancer, CIS of cervix from which the patient has been disease-free for 5 years.
  2. Woman who are pregnant or nursing
  3. Fertile patients unless they agree to use barrier contraception (condoms and spermicide jelly) during the vector infusion period and for six weeks after infusion. Male patients must agree to use barrier contraception.
  4. Patients who are transfusion dependent (more than one transfusion per month)
  5. Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
  6. Patient who do not meet the inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504998

Locations
United States, California
Epeius Clinical Research Unit
San Marino, California, United States, 91108
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, New York
Bruckner Oncology
New York, New York, United States, 10003
Sponsors and Collaborators
Epeius Biotechnologies
Investigators
Principal Investigator: Sant P Chawla, M.D. Epeius Clinical Research Unit/Sarcoma Oncology Center
Principal Investigator: Howard W Bruckner, M.D. Bruckner Oncology
  More Information

No publications provided

Responsible Party: Erlinda M. Gordon, M.D., Epeius Biotechnologies Corporation
ClinicalTrials.gov Identifier: NCT00504998     History of Changes
Other Study ID Numbers: C07-105, FDA-OOPD R01 FD003071-01
Study First Received: July 18, 2007
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Epeius Biotechnologies:
Pancreatic cancer
Rexin-G
Treatment

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013