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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
opioid growth factor
metenkephalin, OGF-opioid growth factor
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metenkephalin, OGF-opioid growth factor

Arm Description

DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2005
Last Updated
September 4, 2018
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00109941
Brief Title
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Acronym
OGF
Official Title
Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metenkephalin, OGF-opioid growth factor
Arm Type
Experimental
Arm Description
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
Intervention Type
Biological
Intervention Name(s)
opioid growth factor
Other Intervention Name(s)
Opioid growth factor or OGF is a 5 amino acid peptide
Intervention Description
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
Intervention Type
Biological
Intervention Name(s)
metenkephalin, OGF-opioid growth factor
Other Intervention Name(s)
opioid growth factor
Intervention Description
OGF given in saline iv 250 ug/kg weekly
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
Response (progressive disease, stable disease, partial response, complete response)
Title
Tumor size
Title
Quality of life
Title
Depression
Title
Opioid growth factor markers

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill P. Smith, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15014352
Citation
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.
Results Reference
background
PubMed Identifier
20890374
Citation
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.
Results Reference
result

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

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