Carcinoma, Squamous Cell of Head and Neck
Conditions
Keywords
head and neck cancer, opioid growth factor
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.
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.
Interventions
BIOLOGICALOpioid Growth Factor
250ug per kilogram weekly IV infusions
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of tumor measured with CT scan | every 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Metastatic development using CT scan | every 3 months |
Other
| Measure | Time frame |
|---|---|
| Pharmacokinetics of OGF | every 4 weeks |
Countries
United States
Outcome results
None listed