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

Head and Neck Cancer Clinical Trial

— SCV-07 OM  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756951
• Other study ID #: SCI-SCV-MUC-P2-001
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2008
• Last updated: November 20, 2009
• Start date: September 2008

Study information

• Verified date: December 2008
• Source: SciClone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• Placebo
Placebo
• SCV-07
0.02 mg/kg
• SCV-07
0.10 mg/kg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SciClone Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No

External Links

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