Head and Neck
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study To Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck
Eligibility Criteria (per protocol dated 01/07/09):
- Recently diagnosed, pathologically confirmed, non-metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment (post-operative subjects are eligible if it has been less than 6 weeks prior to initiation of radiation therapy.
- SUbjects who have a plan to receive standard cisplatin chemotherapy administered every 3 weeks.
- Karnofsky Performance status of at least 60%.
- SUbject not eligible if there is a history of head and neck tumor(s) of the lips, sinuses, salivary glands or unknown primary tumor.
- Subjects not eligible if there has been prior radiation to the head and neck.
- Subject not eligible if there has been curative surgery more than 6 weeks prior to the initiation of radiation therapy.
- Subject not eligible if there is evidence of oral mucositis.
- Subject not eligible if there is chronic immunosuppression.
- Subject not eligible if there are known allergies or intolerance to cisplatin or similar compounds.
- Other criteria, as determined by the protocol.