Treatment of Advanced Head and Neck Cancer

Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II

This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and survival in patients with head and neck cancer who have failed standard therapy.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Squamous Cell of Head and Neck
• Intervention / Treatment: Biological: Opioid Growth Factor

Detailed Description

The major focus of the study will involve assessment of tumor response, patient survival, tolerance to drug, quality of life, depression, pain management and nutrition. During the study we will begin to study the kinetics of opioid growth factor (OGF) exogenous administration and the relationship between plasma OGF levels, stage of disease and length of treatment. Apart from potentially having growth inhibitory action on cancer, OGF may have some psychological and other biological effects which may prove to be beneficial in the patient's treatment. Presently there is no effective therapy or quality of life adjuvants for the 30,000 Americans who develop head and neck cancer yearly.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with severe and unstable cardiovascular disease.
• Treatment naive subjects will not be included for study.
• Patients with poorly controlled diabetes, seizure disorder, primary CNS tumors or known brain metastases will be excluded.
• 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 degrees C.
• Pulse < 60 or > 110
• Systolic blood pressure > 170 or less than 90 are not eligible.
• Patients with nasopharyngeal squamous cell carcinoma will be excluded
• Patients with hypercalcemia will be excluded from this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; Opioid Growth Factor (OGF)	Biological: Opioid Growth Factor; 250ug per kilogram weekly IV infusions; Other Names: endogenous opioid peptide; Met-enkephalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression of tumor measured with CT scan	every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Metastatic development using CT scan	every 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of OGF	every 4 weeks

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: David Goldenberg, MD, Penn State College of Medicine

Publications and helpful links

General 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. doi: 10.1016/0006-8993(89)90425-3. Erratum In: Brain Res 1989 Oct 2;498(2):405.
• Wybran J, Schandene L, Van Vooren JP, Vandermoten G, Latinne D, Sonnet J, De Bruyere 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. doi: 10.1111/j.1749-6632.1987.tb35753.x. No abstract available.
• Zagon IS, McLaughlin PJ. Opioid antagonists inhibit the growth of metastatic murine neuroblastoma. Cancer Lett. 1983 Nov;21(1):89-94. doi: 10.1016/0304-3835(83)90087-3.
• 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. doi: 10.1089/thy.2008.0112.

Helpful Links

• Penn State Hershey Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): September 30, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: head and neck cancer; opioid growth factor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Mitosis Modulators; Narcotics; Analgesics, Opioid; Mitogens; Enkephalins; Opioid Peptides
• Other Study ID Numbers: PSU 23429