Status:

TERMINATED

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

Lead Sponsor:

Milton S. Hershey Medical Center

Collaborating Sponsors:

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 evalu...

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 gastrointes...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT00783172

Start Date

January 1 2009

End Date

October 1 2011

Last Update

September 6 2018

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, United States, 18103

2

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States, 17033