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

Sponsored by:	Epeius Biotechnologies
Information provided by:	Epeius Biotechnologies
ClinicalTrials.gov Identifier:	NCT00504998

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 I Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Evaluation of Safety and Efficacy of Rexin-G for Recurrent or Metastatic Pancreatic Cancer

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 ]

Estimated Enrollment:	24
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Experimental 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.
4: Experimental 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.
5: Experimental 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:

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.

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:	Epeius Biotechnologies Corporation ( Erlinda M. Gordon, M.D. )
Study ID Numbers:	C07-105, FDA-OOPD R01 FD003071-01
Study First Received:	July 18, 2007
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00504998 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epeius Biotechnologies:

Pancreatic cancer
Rexin-G
Treatment

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009