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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00109941
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE May 3, 2005
First Posted Date  ICMJE May 4, 2005
Last Update Posted Date September 6, 2018
Study Start Date  ICMJE October 2003
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
Survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
  • Response (progressive disease, stable disease, partial response, complete response)
  • Tumor size
  • Quality of life
  • Depression
  • Opioid growth factor markers
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Official Title  ICMJE Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Biological: opioid growth factor
    OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
    Other Name: 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 Name: opioid growth factor
Study Arms  ICMJE Experimental: metenkephalin, OGF-opioid growth factor
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
Interventions:
  • Biological: opioid growth factor
  • Biological: metenkephalin, OGF-opioid growth factor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2013)
25
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00109941
Other Study ID Numbers  ICMJE CDR0000425404
FD-R-0002391 ( Other Grant/Funding Number: FDA OOPD Grant FD-R-0002391 )
M01RR010732 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jill P. Smith, MD Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP