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Clinical Trial Record

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

2007-07

2010-07

2011-06

20

Study Overview

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

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.

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.

  • Pancreatic Cancer
  • GENETIC: Rexin-G
  • GENETIC: Rexin-G
  • GENETIC: Rexin-G
  • GENETIC: Rexin-G
  • GENETIC: Rexin-G
  • C07-105
  • FDA-OOPD R01 FD003071-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2007-07-18  

N/A  

2011-06-09  

2007-07-18  

N/A  

2011-06-10  

2007-07-20  

N/A  

2010-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles.24
Secondary Outcome MeasuresMeasure DescriptionTime Frame
To identify an objective tumor response to Rexin-G24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Sant P Chawla, M.D., Epeius Clinical Research Unit/Sarcoma Oncology Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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    NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

    The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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