Treatment of Advanced Head and Neck Cancer With Opioid Growth Factor - Full Text View

Sponsor:	Penn State University
Collaborator:	Milton S. Hershey Medical Center
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00905099

Purpose

The investigators' research group has been studying the mechanisms concerning the origins and course of head and neck squamous cell carcinoma (HNSCC) with the long-range goal of designing strategies for early diagnosis and treatment. Preclinical studies have found that the endogenous (native) opioid peptide [Met5]-enkephalin, termed opioid growth factor (OGF), and its receptor (OGFr) form a tonically active growth inhibitory system that targets cell replication in HNSCC.

The objective of this particular application, which is the next step toward attainment of our long-range goal, is to determine the efficacy of OGF in the treatment of head and neck squamous cell carcinoma. The central hypothesis for the proposed research is that cell proliferation in HNSCC is dependent on the OGF-OGFr axis. The rationale for the proposed investigations is that exogenous administration of OGF to patients with advanced HNSCC will extend survival and improve quality of life by depressing cell replicative events.

Aim #1. Treatment of HNSCC patients with OGF infusions and monitoring of tumor progression and survival.

Aim #2. Evaluate the quality of life of HNSCC patients receiving OGF.

Aim #3. Establish the pharmacokinetics of OGF in plasma of HNSCC patients receiving this peptide.

Condition	Intervention	Phase
Head and Neck Squamous Cell Carcinoma	Biological: Opioid Growth Factor (OGF)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Advanced Head and Neck Cancer With Opioid Growth Factor: Phase II

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

progression of tumor measured with CT scan [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Metastatic development using CT scan [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
pharmacokinetics of OGF [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

OGF will be diluted to its appropriate concentration based upon body weight (250 ug/kg) and administered in 50 ml 0.9% sodium chloride by intravenous infusion over 45 minutes. Patients will receive OGF once weekly for the duration of study, until tumor progression, toxicity or death.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically and cytologically confirmed diagnosis of squamous cell carcinoma
Patients not amenable to curative treatments with further surgery and/or radiation
Patients has failed treatment with chemotherapy
Lesion must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline
Patients must have a Karnofsky performance rating of at least 50%

Exclusion Criteria:

Patients with severe and unstable cardiovascular diseases (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias, poorly controlled hypertension, have suffered a myocardial infarction in the preceding year or have an abnormal EKG)
Treatment naïve subjects will not be included for study
Patients with poorly controlled diabetes, seizure disorders, primary CNS tumors or known brain metastases will be excluded from investigation
Pregnant or nursing women
Patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible
patients with a fever > 37.8°C
pulse less than 60 or greater than 110
systolic blood pressure > 170 or less than 90 are not eligible
Patients with nasopharyngeal squamous cell carcinoma and patients with hypercalcemia will be excluded
Lab Values which warrant exclusion:
- Leukocyte Count < 3.5 K/UL
- Absolute Neutrophil Count < 1.5 K/UL
- Hemoglobin < 8.5 g/dl
- Blood Urea Nitrogen > 30 mg/dL (hydrated)
- Creatinine > 2.0 mg/dL
- Total Bilirubin > 4.0 mg/dL
- Platelet Count < 100,000 / mm 3
- Prothrombin Time > 2 sec over control
- INR (unless on coumarin) > 1.8
- Sodium < 130 mmol/L
- Potassium < 3.2 mmol/L
- Glucose > 300 and < 60 mg/dl
- Calcium > 10.2 mg/dL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905099

Contacts

Contact: Sandra Bingaman, RN	717-531-8108
Contact: Sandra Bingaman, RN	1-800-243-1455 ext 8108

Locations

United States, Pennsylvania
Penn State Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: David Goldenberg, MD
Sub-Investigator: Ian S Zagon, Ph.D.
Sub-Investigator: Patricia J. McLaughlin, Ph.D.
Sub-Investigator: Joseph Drabick, MD
Sub-Investigator: Sandra Bingaman, RN
Sub-Investigator: Jill P Smith, MD

Sponsors and Collaborators

Penn State University

Milton S. Hershey Medical Center

Investigators

Principal Investigator:

David Goldenberg, MD

Penn State Hershey Medical Center

More Information

Additional Information:

Penn State Hershey Cancer Institute This link exits the ClinicalTrials.gov site

Publications:

Zagon IS, McLaughlin PJ. Endogenous opioid systems regulate growth of neural tumor cells in culture. Brain Res. 1989 Jun 19;490(1):14-25. Erratum in: Brain Res 1989 Oct 2;498(2):405.

Wybran J, Schandené L, Van Vooren JP, Vandermoten G, Latinne D, Sonnet J, De Bruyère M, Taelman H, Plotnikoff NP. Immunologic properties of methionine-enkephalin, and therapeutic implications in AIDS, ARC, and cancer. Ann N Y Acad Sci. 1987;496:108-14. No abstract available.

Zagon IS, McLaughlin PJ. Opioid antagonists inhibit the growth of metastatic murine neuroblastoma. Cancer Lett. 1983 Nov;21(1):89-94.

Goldenberg D, Zagon IS, Fedok F, Crist HS, McLaughlin PJ. Expression of opioid growth factor (OGF)-OGF receptor (OGFr) axis in human nonmedullary thyroid cancer. Thyroid. 2008 Nov;18(11):1165-70.

Responsible Party:	Penn State Milton S. Hershey Medical Center ( Jill P. Smith, MD )
Study ID Numbers:	23429, IRB 23429
Study First Received:	May 18, 2009
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00905099 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

Head and Neck Cancer
Opioid Growth Factor

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Mitosis Modulators
Central Nervous System Depressants
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Sensory System Agents

Therapeutic Uses
Head and Neck Neoplasms
Mitogens
Peripheral Nervous System Agents
Analgesics
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Central Nervous System Agents
Analgesics, Opioid
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010