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
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.
1 other identifier
interventional
59
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 12, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedNovember 23, 2009
December 1, 2008
September 12, 2008
November 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
1
PLACEBO COMPARATORPlacebo
2
ACTIVE COMPARATORSCV-07 at a dose of 0.02 mg/kg
3
ACTIVE COMPARATORSCV-07 at a dose of 0.10 mg/kg
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, 85013, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Whittingham Cancer Center
Norwalk, Connecticut, 06856, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
James Graham Brown Cancer Center
Lousiville, Kentucky, 40202, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University in St Louis
St Louis, Missouri, 63110, United States
The Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Ohio State University Medical Center
Columbis, Ohio, 43210, United States
St Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Israel Rios, MD
SciClone Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2008
First Posted
September 22, 2008
Study Start
September 1, 2008
Last Updated
November 23, 2009
Record last verified: 2008-12