Treatment of Advanced Head and Neck Cancer

Stopped early · Phase 2

Conditions studied: Carcinoma, Squamous Cell of Head and Neck

In brief

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.

Key facts

Study ID

NCT00982696

Run by

Milton S. Hershey Medical Center

People needed

5

Starts

2008-02-01

Expected to finish

2011-11-01

Last updated by the study team

2014-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%.

You may not qualify if…

• 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

Where it is running

• Penn State College of Medicine, Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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