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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-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.

Conditions
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Oral Mucositis, Head and Neck Cancer

Intervention / Treatment
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* Drug: Placebo
* Drug: SCV-07
* Drug: SCV-07


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have a body weight less than 150 kg at screening Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy. Plan to receive a continuous course of conventional external beam irradiation Plan to receive a standard cisplatin chemotherapy regimen Exclusion Criteria: Pregnant or breastfeeding Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor Prior radiation to the head and neck Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy Had curative surgery more than 6 weeks prior to the initiation of radiotherapy Have current oral mucositis Presence of active infectious disease excluding oral candidiasis Chronic immunosuppression Seropositive for HIV or hepatitis B surface antigen or C antibody Used an investigational agent within 30 days of randomization Have a known sensitivity to any investigational agent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: 2<br>SCV-07 at a dose of 0.02 mg/kg | Drug: SCV-07<br>* 0.02 mg/kg<br>|
| Active Comparator: 3<br>SCV-07 at a dose of 0.10 mg/kg | Drug: SCV-07<br>* 0.10 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy. |  | 7 Weeks | 
| Efficacy of Oral Mucositis assessment will be completed by trained site personnel. The WHO score will be the primary measure and NCI CTCAE will be a secondary measure for assessing Oral Mucositis. |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCV-07, Oral Mucositis