Opioid Growth Factor (OGF) and Gemcitabine: Novel Treatment for Pancreatic Cancer

This study is currently recruiting participants.

Verified by Penn State University, May 2009

First Received: October 30, 2008 Last Updated: May 1, 2009 History of Changes

Sponsor:	Penn State University
Collaborators:	Milton S. Hershey Medical Center National Institutes of Health (NIH)
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00783172

Purpose

It is hypothesized that OGF biotherapy may be safely administered in combination with gemcitabine to individuals with unresectable pancreatic cancer. The study includes two aims, the first is to evaluate the safety and toxicity of the combination of OGF and gemcitabine chemotherapy. The second aim of the trial is to study the efficacy of OGF and gemcitabine when used in combination.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: Gemcitabine Biological: Opioid Growth Factor (OGF)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

progression measured with CT scan [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

1000mg/m2, IV (in the vein) over 30 minutes after treatment with OGF; first cycle is consecutive seven weeks and one week off; subsequent cycles are three weeks on and one week off.

Initial treatment is 150ug/kg (based on body weight of the patient) in a volume of 50ml sterile saline, IV (in the vein) over 45 minutes; subsequent treatments at dose of 250ug/kg

Eligibility

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

Criteria

Inclusion Criteria:

unresectable and histological or cytological confirmation of adenocarcinoma of the pancreas and measurable disease by CT scan
patient has not been previously treated for pancreatic cancer

Exclusion Criteria:

history of cancer other than pancreatic cancer (excluding resected basal cell skin cancer or curative stage 1 cervical cancer if disease free for 5 years or more)
previous treatment with chemotherapy for pancreatic cancer
uncontrolled cardiovascular disease (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias)
suffered from myocardial infarction in preceding 6 months
poorly controlled medical conditions including: asthma, chronic obstructive pulmonary disease, diabetes, seizure disorders, known brain metastases, hepatic or renal failure
pregnant or nursing women
known allergy to gemcitabine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783172

Contacts

Contact: Sandra I Bingaman, RN	717-531-8108	sbingaman@hmc.psu.edu
Contact: Krystal R Anson, BS	717-531-5519	kanson@hmc.psu.edu

Locations

United States, Pennsylvania
Penn State Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sandra I Bingaman, RN 717-531-8108 sbingaman@hmc.psu.edu
Contact: Krystal R Anson, BS 717-531-5519 kanson@hmc.psu.edu
Principal Investigator: Jill P Smith, MD
Sub-Investigator: Matthew Moyer, MD
Sub-Investigator: Ian S Zagon, PhD
Sub-Investigator: Harold A Harvey, MD
Lehigh Valley Hospital and Health Network	Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Gregory Harper, MD, PhD 610-402-7880 gregory.harper@lvh.com
Principal Investigator: Gregory Harper, MD, PhD

Sponsors and Collaborators

Penn State University

Milton S. Hershey Medical Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Jill P Smith, MD

Penn State University

More Information

Additional Information:

Penn State Hershey Clinical Trials Office This link exits the ClinicalTrials.gov site

Penn State Hershey General Clinical Research Center This link exits the ClinicalTrials.gov site

Publications:

Zagon IS, Jaglowski JR, Verderame MF, Smith JP, Leure-Dupree AE, McLaughlin PJ. Combination chemotherapy with gemcitabine and biotherapy with opioid growth factor (OGF) enhances the growth inhibition of pancreatic adenocarcinoma. Cancer Chemother Pharmacol. 2005 Nov;56(5):510-20. Epub 2005 Jun 10.

Smith JP, Conter RL, Bingaman SI, Harvey HA, Mauger DT, Ahmad M, Demers LM, Stanley WB, McLaughlin PJ, Zagon IS. Treatment of advanced pancreatic cancer with opioid growth factor: phase I. Anticancer Drugs. 2004 Mar;15(3):203-9.

Zagon IS, Smith JP, McLaughlin PJ. Human pancreatic cancer cell proliferation in tissue culture is tonically inhibited by opioid growth factor. Int J Oncol. 1999 Mar;14(3):577-84.

Zagon IS, Hytrek SD, Smith JP, McLaughlin PJ. Opioid growth factor (OGF) inhibits human pancreatic cancer transplanted into nude mice. Cancer Lett. 1997 Jan 30;112(2):167-75.

Responsible Party:	Penn State College of Medicine, Penn State Milton S. Hershey ( Jill P Smith, MD )
Study ID Numbers:	PSU-20978, 1R03CA129581-01A2
Study First Received:	October 30, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00783172 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

pancreas
pancreatic cancer
cancer
Opioid Growth Factor

OGF
gemcitabine
chemotherapy

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Mitogens
Analgesics
Gemcitabine
Analgesics, Opioid

Endocrine Gland Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Central Nervous System Depressants
Endocrine System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Pancreatic Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009