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

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer Squamous Cell Carcinoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression of tumor measured with CT scan

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

David Goldenberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State College of Medicine


United States: Food and Drug Administration

Study ID:

PSU 23429



Start Date:

February 2008

Completion Date:

November 2011

Related Keywords:

  • Head and Neck Cancer Squamous Cell Carcinoma
  • head and neck cancer
  • opioid growth factor
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasms, Squamous Cell



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