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

Completed · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis, Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT00756951

Run by

SciClone Pharmaceuticals

People needed

59

Starts

2008-09-01

Last updated by the study team

2009-11-23

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arizona Oncology Services Foundation — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Whittingham Cancer Center — Norwalk, Connecticut, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• James Graham Brown Cancer Center — Lousiville, Kentucky, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University in St Louis — St Louis, Missouri, United States
• The Nebraska Medical Center — Omaha, Nebraska, United States
• Beth Israel Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Mid Dakota Clinic — Bismarck, North Dakota, United States
• Ohio State University Medical Center — Columbis, Ohio, United States
• St Luke's Hospital & Health Network — Bethlehem, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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