Treatment of Advanced Head and Neck Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer Squamous Cell Carcinoma	Biological: Opioid Growth Factor	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Head and Neck Cancer Nuclear Scans

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

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 ]

Other Outcome Measures:

Pharmacokinetics of OGF [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	February 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Arm Opioid Growth Factor (OGF)	Biological: Opioid Growth Factor 250ug per kilogram weekly IV infusions Other Names: endogenous opioid peptide Met-enkephalin

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.

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982696

Locations

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

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

Principal Investigator:

David Goldenberg, MD

Penn State College of Medicine

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:	David Goldenberg, Associate Professor of Medicine and Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:	NCT00982696 History of Changes
Obsolete Identifiers:	NCT00905099
Other Study ID Numbers:	PSU 23429
Study First Received:	September 22, 2009
Last Updated:	May 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:

head and neck cancer
opioid growth factor

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Mitogens
Endorphins
Opioid Peptides
Analgesics, Opioid

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 18, 2013