This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
Placebo
Arizona Center for Cancer Care
Peoria, Arizona, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Efficacy
The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.
Time frame: June 2012
Safety
The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.
Time frame: June 2012
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disney Family Cancer Center
Burbank, California, United States
City of Hope National Medical Center
Duarte, California, United States
VA Long Beach Health System
Long Beach, California, United States
Pomona Valley Hospital
Pomona, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
...and 39 more locations