drugset / Trial / NCT00756951

Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

NCT00756951 ↗

Phase 2 Completed 59 enrolled SciClone Pharmaceuticals
RandomizedSingle-groupDouble-blindHealth-services research

Summary

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer. The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.

Timeline

Start
2008-09
Primary completion
—
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Comparator GOLOTIMOD Peptide 0.02 mg/kg —
Comparator GOLOTIMOD Peptide 0.1 mg/kg —