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)

November 20, 2009 updated by: SciClone Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Arizona Oncology Services Foundation
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Kentucky
      • Lousiville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University in St Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • The Nebraska Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
    • Ohio
      • Columbis, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St Luke's Hospital & Health Network
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Drug: SCV-07
0.10 mg/kg
Active Comparator: 3
SCV-07 at a dose of 0.10 mg/kg
Drug: SCV-07
0.02 mg/kg
Drug: SCV-07
0.10 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SciClone Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

November 23, 2009

Last Update Submitted That Met QC Criteria

November 20, 2009

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-SCV-MUC-P2-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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