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OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I
Expanded access is currently available for this treatment.
Verified by Penn State University, September 2008
Sponsors and Collaborators: Penn State University
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
Pancreatic Cancer
 Drug: Gemcitabine
Biological: Opioid Growth Factor (OGF)

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Expanded Access
Official Title: OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study

Further study details as provided by Penn State University:

Intervention Details:
    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.
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Hershey, Pennsylvania, United States, 17033
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States, 18103
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

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: October 30, 2008
ClinicalTrials.gov Identifier: NCT00783172  
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
pancreas
pancreatic cancer
cancer
Opioid Growth Factor
 OGF
gemcitabine
chemotherapy

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
 Endocrinopathy
Gemcitabine
Pancrelipase
Enkephalins
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
 Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009



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