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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783172
Recruitment Status : Terminated (Problems with IRB)
First Posted : October 31, 2008
Last Update Posted : February 13, 2013
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jill P. Smith, Penn State University

Brief Summary:
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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine Biological: Opioid Growth Factor (OGF) Phase 1

Detailed Description:
Pancreatic cancer is the 4th leading cause of cancer-related deaths in the United States with a median survival of 3-6 months and a five-year survival rate of 1% making it the worse of all gastrointestinal malignancies. The reason for the poor prognosis is related to failure to diagnose this cancer in early stages and the unresponsiveness of pancreatic cancer to conventional chemotherapy and radiation therapy. Gemcitabine has become the standard of care in treatment of advanced pancreatic cancer; however, the mean survival with gemcitabine is reported at only 5.6 months. Our research team has discovered a novel biotherapy called Opioid Growth Factor (OGF) that inhibits growth of pancreatic cancer in vitro, in animals, and in human subjects. A Phase 1 study with OGF has been completed and the maximum tolerated dose, safety and toxicity evaluated. Currently a Phase 2 trial is in progress to study the efficacy of OGF monotherapy in those who have not responded to standard treatment. Recent experiments from our basic science laboratories indicate a marked additive benefit in cancer inhibition when OGF is combined with gemcitabine. Additionally, animals receiving the combination regime were healthier than those treated with gemcitabine alone suggesting perhaps a protective effect of OGF to chemotherapy toxicity. It is hypothesized that OGF may be safely administered in combination with gemcitabine to individuals with unresectable pancreatic cancer. In order to test this hypothesis 22 eligible naïve patients with pancreatic cancer will be prospectively treated with standard doses of gemcitabine. Concomitantly, OGF will be administered weekly starting at 150 μg/kg and increasing to the Maximum tolerated dose of 250 μg/kg in order to determine the following specific aims: 1) evaluate the safety and toxicity of the combination of OGF biotherapy and gemcitabine; 2) determine whether the combination therapy alters the pharmacokinetics of either agent; and 3) study the efficacy of combination therapy on tumor size, patient survival, and time to progression of disease. The long-term goal of our research team involves translation of novel discoveries from the basic science laboratory into clinical practice with the ultimate goal of improving survival of patients with this devastating disease.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study
Study Start Date : January 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: OGF & Gemcitabine
Opioid Growth factor 250 ug/kg IV once a week. Gemcitabine 1000 mg/m2 weekly for 7 out of 8 weeks induction then every 3 out of 4 week cycles.
Drug: Gemcitabine
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.
Other Name: Gemzar
Biological: Opioid Growth Factor (OGF)
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
Other Name: [Met]5-enkephalin

Primary Outcome Measures :
  1. progression measured with CT scan [ Time Frame: every 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783172

United States, Pennsylvania
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States, 18103
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Jill P. Smith
Milton S. Hershey Medical Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: Jill P Smith, MD Penn State University

Additional Information:
Responsible Party: Jill P. Smith, Professor Emeritus of Medicine, Penn State University Identifier: NCT00783172     History of Changes
Other Study ID Numbers: PSU-20978 and 35686EP
1R03CA129581 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Jill P. Smith, Penn State University:
pancreatic cancer
Opioid Growth Factor

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Analgesics, Opioid
Enkephalin, Methionine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Mitosis Modulators
Neurotransmitter Agents