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

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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

May 3, 2005
May 4, 2005
September 6, 2018
October 2003
September 2007   (Final data collection date for primary outcome measure)
Survival
Not Provided
Complete list of historical versions of study NCT00109941 on ClinicalTrials.gov Archive Site
  • Response (progressive disease, stable disease, partial response, complete response)
  • Tumor size
  • Quality of life
  • Depression
  • Opioid growth factor markers
Not Provided
Not Provided
Not Provided
 
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
April 2009
September 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00109941
CDR0000425404
FD-R-0002391 ( Other Grant/Funding Number: FDA OOPD Grant FD-R-0002391 )
M01RR010732 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Study Chair: Jill P. Smith, MD Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
March 2013

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