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 - Full Text View

Sponsored by:	SciClone Pharmaceuticals
Information provided by:	SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00756951

Purpose

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.

Condition	Intervention	Phase
Oral Mucositis Head and Neck Cancer	Drug: Placebo Drug: SCV-07	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Golotimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by SciClone Pharmaceuticals:

Primary Outcome Measures:

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. [ Time Frame: 7 Weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo Placebo
2: Active Comparator SCV-07 at a dose of 0.02 mg/kg	Drug: SCV-07 0.02 mg/kg
3: Active Comparator SCV-07 at a dose of 0.10 mg/kg	Drug: SCV-07 0.10 mg/kg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756951

Contacts

Contact: Beth Rayworth, M.S.	508-620-2700	brayworth@captrials.com
Contact: Tom Guntly	650-358-3464	tguntly@sciclone.com

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Andrei Barasch, M.D. 205-996-4418 abarasch@uab.edu
Principal Investigator: Andrei Barasch, DMD, MDSc, FAAHD
United States, Arizona
Arizona Oncology Services Foundation	Recruiting
Phoenix, Arizona, United States, 85013
Contact: Theresa Thomas 602-274-4484 tthomas@healthcare.org
Principal Investigator: David Brachman, MD
United States, Arkansas
University of Arkansas for Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Karen Duvall 501-686-5025 kduvall@uams.edu
Principal Investigator: James Suen, MD
United States, Connecticut
Whittingham Cancer Center	Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Linda Versea 203-855-3517 linda.versea@norwalkhealth.org
Principal Investigator: Pradip Pathare, MD
United States, Illinois
University of Illinois at Chicago	Recruiting
Chicago, Illinois, United States, 60612
Contact: Marcia Stout 312-996-2937 mstout@uic.edu
Principal Investigator: Joel Epstein, DMD
United States, Kentucky
James Graham Brown Cancer Center	Recruiting
Lousiville, Kentucky, United States, 40202
Contact: Holly Bennett 502-217-5229 hlbenn03@gwise.louisville.edu
Principal Investigator: Zafrulla Khan, DDS, MS
United States, Michigan
Karmanos Cancer Institute	Recruiting
Detroit, Michigan, United States, 48201
Contact: Paulette Palazzolo 313-745-2472 palazzol@karmanos.org
Principal Investigator: Harold Kim, MD
United States, Missouri
Washington University in St Louis	Recruiting
St Louis, Missouri, United States, 63110
Contact: Jessica Ley 314-747-8092 jley@dom.wustl.edu
Principal Investigator: Douglas Adkins, MD
United States, Nebraska
The Nebraska Medical Center	Recruiting
Omaha, Nebraska, United States, 68198
Contact: Erin Reed 402-552-2283 ereed@nebraskamed.com
Principal Investigator: Weining Zhen, MD
United States, New York
Beth Israel Medical Center	Recruiting
New York, New York, United States, 10003
Contact: Mahesh Kumar 212-844-8030 mkumar@chpnet.org
Principal Investigator: Kenneth Hu, MD
United States, North Carolina
Carolinas Medical Center	Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jenene Noll 704-355-9120 Jenene.Noll@carolinashealthcare.org
Principal Investigator: Michael Brennan, DDS, MHS
United States, Pennsylvania
Temple University	Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Jennifer Curry 215-707-7471 jennifer.curry@tuhs.temple.edu
Principal Investigator: Curtis Miyamoto, MD
St Luke's Hospital & Health Network	Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Rose Cabral 610-954-6013 cabralr@slhn.org
Principal Investigator: Sanjiv Agarwala, MD
United States, Wisconsin
Medical College of Wisconsin	Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Anna Koziel 414-805-0261 akoziel@mcw.edu
Principal Investigator: Christopher Schultz, MD

Sponsors and Collaborators

SciClone Pharmaceuticals

Investigators

Study Director:

Israel Rios, MD

SciClone Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	SciClone Pharmaceuticals, Inc. ( Israel Rios, MD )
Study ID Numbers:	SCI-SCV-MUC-P2-001
Study First Received:	September 12, 2008
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00756951 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:

SCV-07
Oral Mucositis

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Mouth Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Stomatitis

Mucositis
Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009