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

This study has been terminated.
(Problems with IRB)
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Jill P. Smith, Penn State University
ClinicalTrials.gov Identifier:
NCT00783172
First received: October 30, 2008
Last updated: February 11, 2013
Last verified: February 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study

Resource links provided by NLM:


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 ]

Enrollment: 4
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Jill P Smith, MD Penn State University
  More Information

Additional Information:
Publications:
Responsible Party: Jill P. Smith, Professor Emeritus of Medicine, Penn State University
ClinicalTrials.gov Identifier: NCT00783172     History of Changes
Other Study ID Numbers: PSU-20978 and 35686EP, 1R03CA129581
Study First Received: October 30, 2008
Last Updated: February 11, 2013
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:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Mitogens
Gemcitabine
Analgesics, Opioid
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014