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Treatment of Advanced Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00982696
Recruitment Status : Terminated (Deemed ineffective)
First Posted : September 23, 2009
Last Update Posted : September 30, 2014
Information provided by (Responsible Party):
David Goldenberg, Milton S. Hershey Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Squamous Cell of Head and Neck Biological: Opioid Growth Factor Phase 2

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  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II
Study Start Date : February 2008
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Progression of tumor measured with CT scan [ Time Frame: every 3 months ]

Secondary Outcome Measures :
  1. Metastatic development using CT scan [ Time Frame: every 3 months ]

Other Outcome Measures:
  1. Pharmacokinetics of OGF [ Time Frame: every 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982696

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
Principal Investigator: David Goldenberg, MD Penn State College of Medicine

Additional Information:
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
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014

Keywords provided by David Goldenberg, Milton S. Hershey Medical Center:
head and neck cancer
opioid growth factor

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Analgesics, Opioid
Enkephalin, Methionine
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents