NCT00109941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Timeline
Completed

Started Oct 2003

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 6, 2018

Status Verified

March 1, 2013

Enrollment Period

3.9 years

First QC Date

May 3, 2005

Last Update Submit

September 4, 2018

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (5)

  • Response (progressive disease, stable disease, partial response, complete response)

  • Tumor size

  • Quality of life

  • Depression

  • Opioid growth factor markers

Study Arms (1)

metenkephalin, OGF-opioid growth factor

EXPERIMENTAL

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

Biological: opioid growth factorBiological: metenkephalin, OGF-opioid growth factor

Interventions

opioid growth factorBIOLOGICAL

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
metenkephalin, OGF-opioid growth factor
metenkephalin, OGF-opioid growth factorBIOLOGICAL

OGF given in saline iv 250 ug/kg weekly

Also known as: opioid growth factor
metenkephalin, OGF-opioid growth factor

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Related Publications (2)

  • 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.

    PMID: 15014352BACKGROUND

  • 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.

    PMID: 20890374RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Enkephalin, Methionine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EnkephalinsOpioid PeptidesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Jill P. Smith, MD

    Milton S. Hershey Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

October 1, 2003

Primary Completion

September 1, 2007

Study Completion

April 1, 2009

Last Updated

September 6, 2018

Record last verified: 2013-03

Locations

US(1)