Pancreatic CancerPhase 2OGFNCT00109941
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
A Phase 2 study testing opioid growth factor and metenkephalin, OGF-opioid growth factor in people with Pancreatic Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- opioid growth factor and metenkephalin, OGF-opioid growth factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Apr 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 20Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
Official title: 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.
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.
- Conditions
- Pancreatic Cancer
- Being tested
- opioid growth factor, metenkephalin, OGF-opioid growth factor
- Keywords
- recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid growth factorBiological
Also called Opioid growth factor or OGF is a 5 amino acid peptide
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
metenkephalin, OGF-opioid growth factorBiological
Also called opioid growth factor
OGF given in saline iv 250 ug/kg weekly
| Study group | Role | What they receive |
|---|---|---|
| metenkephalin, OGF-opioid growth factor | Experimental | DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes Receives: Biological: opioid growth factor; Biological: metenkephalin, OGF-opioid growth factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Secondary outcomes (5)
Response (progressive disease, stable disease, partial response, complete response)
Tumor size
Quality of life
Depression
Opioid growth factor markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startOct 2003
- Primary completionSep 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill P. Smith, MD, Study chair, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109941
- Sponsor's protocol ID
- CDR0000425404
- Other IDs
- FD-R-0002391, M01RR010732
- Acronym
- OGF
- Status last verified
- Mar 2013
- First submitted
- 3 May 2005
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 15014352Smith 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
- ClinicalTrials.gov ID
- NCT00109941
- Acronym / sponsor ID
- OGF / CDR0000425404
- Conditions
- Pancreatic Cancer
- Keywords
- recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metenkephalin, OGF-opioid growth factor | Experimental | Biological: opioid growth factor, Biological: metenkephalin, OGF-opioid growth factorDRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (20 listed)
- No primary CNS tumors or known brain metastases Cardiovascular
- - congestive heart failure
- symptoms of coronary artery disease
- cardiac arrhythmia
- poorly controlled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opioid growth factorAlso: Opioid growth factor or OGF is a 5 amino acid peptideOGF was administered in saline at 250 ug/kg intravenously over 45 minutes | Biological | metenkephalin, OGF-opioid growth factor |
| metenkephalin, OGF-opioid growth factorAlso: opioid growth factorOGF given in saline iv 250 ug/kg weekly | Biological | metenkephalin, OGF-opioid growth factor |
Primary outcome
Survival
5 secondary outcomes
Response (progressive disease, stable disease, partial response, complete response)
Tumor size
Quality of life
Depression
Opioid growth factor markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 15014352Smith 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 publication: PubMed 20890374Smith 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.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill P. Smith, MD study chair
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing opioid growth factor and metenkephalin, OGF-opioid growth factor in people with Pancreatic Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00109941, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.