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

NCT00783172 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-09-06

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Jill P Smith, MD · Penn State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-08-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00783172 on ClinicalTrials.gov