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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Golotimod

U.S. FDA Resources

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:	59
Study Start Date:	September 2008

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

Show 19 Study Locations

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:	Israel Rios, MD, SciClone Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00756951 History of Changes
Other Study ID Numbers:	SCI-SCV-MUC-P2-001
Study First Received:	September 12, 2008
Last Updated:	November 20, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:

SCV-07
Oral Mucositis

Additional relevant MeSH terms:

Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms

Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012