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 (SCV-07 OM)

SciClone Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis; Head and Neck Cancer

Treatments: Drug: SCV-07; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756951

SCI-SCV-MUC-P2-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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59 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

SCV-07 at a dose of 0.02 mg/kg

Treatment:

Drug: SCV-07

Drug: SCV-07

3

Active Comparator group

Description:

SCV-07 at a dose of 0.10 mg/kg

Treatment:

Drug: SCV-07

Drug: SCV-07