Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II
18 Years
N/A
Both
Head and Neck Cancer Squamous Cell Carcinoma
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:
Interventional
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:
Yes
Principal Investigator
David Goldenberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Penn State College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
PSU 23429
NCT ID:
NCT00982696
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
Name | Location |
|---|---|
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
