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CompletedNCT00109941OGFUpdated Sep 6, 2018

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

A Phase 2 interventional study of opioid growth factor and metenkephalin, OGF-opioid growth factor in Pancreatic Cancer, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 25 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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 · Biological: metenkephalin, OGF-opioid growth factor

Interventions

  • Biologicalopioid growth factor

    OGF was administered in saline at 250 ug/kg intravenously over 45 minutes

    Also known as: Opioid growth factor or OGF is a 5 amino acid peptide

  • Biologicalmetenkephalin, OGF-opioid growth factor

    OGF given in saline iv 250 ug/kg weekly

    Also known as: opioid growth factor

06

What researchers measure

Primary outcomes

  1. Survival

Secondary outcomes

  1. Response (progressive disease, stable disease, partial response, complete response)

  2. Tumor size

  3. Quality of life

  4. Depression

  5. Opioid growth factor markers

07

Study locations

1 site
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
08

References and documents

Publications

  • 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. doi: 10.1097/00001813-200403000-00003. PubMed 15014352 ↗
  • Smith JP, Bingaman SI, Mauger DT, Harvey HH, Demers LM, Zagon IS. Opioid growth factor improves clinical benefit and survival in patients with advanced pancreatic cancer. Open Access J Clin Trials. 2010 Mar 1;2010(2):37-48. doi: 10.2147/oajct.s8270. PubMed 20890374 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00109941
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Sponsor
First posted
May 4, 2005
Start date
Oct 2003
Primary completion
Sep 2007
Completion
Apr 2009
Last update
Sep 6, 2018

Study contacts

Jill P. Smith, MD
study chair · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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