Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery (OGF)

September 4, 2018 updated by: Milton S. Hershey Medical Center

Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II

RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the growth inhibitory effects of opioid growth factor ([Met^5]-enkephalin) in patients with advanced unresectable pancreatic cancer.

Secondary

  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.
  • Determine the pain control, depression, and nutritional status of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive opioid growth factor ([Met^5]-enkephalin) IV over 45 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 weeks during study treatment, and at the completion of study treatment.

Patients are followed weekly for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Diagnosis of pancreatic cancer
  • Advanced, unresectable disease
  • Must have failed OR refused prior standard chemotherapy (e.g., gemcitabine or fluorouracil) for pancreatic cancer
  • Measurable disease by radiography
  • Age Over 18
  • Performance status Karnofsky 50-100%
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm^3
  • WBC ≥ 3,500/mm^3
  • Hemoglobin ≥ 8.5 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 4.0 mg/dL (stents allowed)
  • PT or INR ≤ 2 seconds over control OR ≤ 1.8 (unless on warfarin) renal & metabolic
  • BUN ≤ 30 mg/dL (hydrated)
  • Creatinine ≤ 2.0 mg/dL
  • Sodium ≥ 130 mmol/L
  • Potassium ≥ 3.2 mmol/L
  • Glucose 60-300 mg/dL
  • Pulse 60-110 beats/minute
  • Systolic blood pressure 90-170 mm Hg

Exclusion Criteria

  • No primary CNS tumors or known brain metastases Cardiovascular
  • - congestive heart failure
  • symptoms of coronary artery disease
  • cardiac arrhythmia
  • poorly controlled hypertension
  • myocardial infarction within the past year
  • abnormal EKG
  • asthma
  • hronic obstructive pulmonary disease
  • pregnant or nursing
  • Fertile patients must use effective contraception
  • serious infection requiring antibiotics within the past 2 weeks
  • poorly controlled diabetes
  • seizure disorders
  • fever > 37.8° C
  • other malignancy within the past 5 years
  • concurrent chemotherapy
  • concurrent oral steroids
  • concurrent radiotherapy
  • Surgery within 4 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: metenkephalin, OGF-opioid growth factor
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
Biological: opioid growth factor
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
Other Names:
  • Opioid growth factor or OGF is a 5 amino acid peptide
Biological: metenkephalin, OGF-opioid growth factor
OGF given in saline iv 250 ug/kg weekly
Other Names:
  • opioid growth factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Depression
Quality of life
Response (progressive disease, stable disease, partial response, complete response)
Tumor size
Opioid growth factor markers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Study Chair: Jill P. Smith, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

May 3, 2005

First Submitted That Met QC Criteria

May 3, 2005

First Posted (Estimate)

May 4, 2005

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000425404
  • M01RR010732 (U.S. NIH Grant/Contract)
  • FD-R-0002391 (Other Grant/Funding Number: FDA OOPD Grant FD-R-0002391)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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