- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00504998
Safety/Efficacy Study of Rexin-G to Treat Pancreatic Cancer
June 9, 2011 updated by: Epeius Biotechnologies
Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Marino, California, United States, 91108
- Epeius Clinical Research Unit
-
Santa Monica, California, United States, 90403
- Sarcoma Oncology Center
-
-
New York
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New York, New York, United States, 10003
- Bruckner Oncology
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically confirmed recurrent or metastatic pancreatic cancer that has failed gemcitabine and that is measurable.
- 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.
- Performance status must be < 1 (ECOG 0-1) with a life expectancy of at least 3 months.
- Hemoglobin > 9 gms%
- Absolute granulocyte count > 1000/uL, and platelet count > 100,000/uL.
- Serum creatinine of less than 1.5 mg%.
- 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.
- Accessibility of peripheral or central IV line
- Age > 10 years
- 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.
- The ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- 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.
- Woman who are pregnant or nursing
- 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.
- Patients who are transfusion dependent (more than one transfusion per month)
- Patients with medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
- Patient who do not meet the inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Dose Level 1 of escalating doses of Rexin-G i.v.
|
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.
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.
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.
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.
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.
|
EXPERIMENTAL: 3
Dose Level 3 of escalating doses of Rexin-G i.v.
|
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.
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.
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.
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.
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.
|
EXPERIMENTAL: 4
Dose Level 4 of escalating doses of Rexin-G i.v.
|
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.
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.
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.
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.
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.
|
EXPERIMENTAL: 5
Dose Level 5 of escalating doses of Rexin-G i.v.
|
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.
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.
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.
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.
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.
|
EXPERIMENTAL: 2
Dose Level 2 of escalating doses of Rexin-G i.v.
|
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.
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical toxicity (DLT and MTD) as defined by patient performance status, toxicity assessment score, hematologic, and metabolic profiles.
Time Frame: 24
|
24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify an objective tumor response to Rexin-G
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
July 1, 2007
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
July 18, 2007
First Submitted That Met QC Criteria
July 18, 2007
First Posted (ESTIMATE)
July 20, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
June 10, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C07-105
- FDA-OOPD R01 FD003071-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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