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. 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

September 22, 2009
September 23, 2009
September 30, 2014
February 2008
November 2011   (Final data collection date for primary outcome measure)
Progression of tumor measured with CT scan [ Time Frame: every 3 months ]
Evaluate the growth inhibitory effects of OGF by treating patients with advanced head and neck cancer who have failed prior therapy (surgery, radiation, or chemotherapy) in a prospective study. [ Time Frame: 24 months ]
Complete list of historical versions of study NCT00982696 on Archive Site
Metastatic development using CT scan [ Time Frame: every 3 months ]
To study the pharmacokinetics of OGF when given chronically by examining blood OGF levels before and during the infusions. Elucidate the effects of OGF on the quality of life, pain control and depression in patients with advanced head and neck cancer by [ Time Frame: 24 months ]
Pharmacokinetics of OGF [ Time Frame: every 4 weeks ]
Not Provided
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.
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Squamous Cell of Head and Neck
Biological: Opioid Growth Factor
250ug per kilogram weekly IV infusions
Other Names:
  • endogenous opioid peptide
  • Met-enkephalin
Experimental: Single Arm
Opioid Growth Factor (OGF)
Intervention: Biological: Opioid Growth Factor

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
PSU 23429
Not Provided
Not Provided
David Goldenberg, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: David Goldenberg, MD Penn State College of Medicine
Milton S. Hershey Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP