Status:
TERMINATED
Treatment of Advanced Head and Neck Cancer
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Carcinoma, Squamous Cell of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00982696
Start Date
February 1 2008
End Date
November 1 2011
Last Update
September 30 2014
Active Locations (1)
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1
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033