SCV-07 OM: 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

Sponsor

SciClone Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00756951

Collaborator

(none)

Enrollment

Locations

Arms

3.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis Head and Neck Cancer	Drug: Placebo Drug: SCV-07 Drug: SCV-07	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, 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.

Study Start Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Oncology Services Foundation	Phoenix	Arizona	United States	85013
3	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	Whittingham Cancer Center	Norwalk	Connecticut	United States	06856
5	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
6	University of Illinois at Chicago	Chicago	Illinois	United States	60612
7	James Graham Brown Cancer Center	Lousiville	Kentucky	United States	40202
8	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
9	Washington University in St Louis	St Louis	Missouri	United States	63110
10	The Nebraska Medical Center	Omaha	Nebraska	United States	68198
11	Montefiore Medical Center	Bronx	New York	United States	10467
12	Beth Israel Medical Center	New York	New York	United States	10003
13	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
14	Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
15	Ohio State University Medical Center	Columbis	Ohio	United States	43210
16	St Luke's Hospital & Health Network	Bethlehem	Pennsylvania	United States	18015
17	Temple University	Philadelphia	Pennsylvania	United States	19140
18	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232
19	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226