Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

SciClone Pharmaceuticals

Conditions:

Oral Mucositis

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 app...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

59 Patients enrolled

Trial Details

Trial ID

NCT00756951

Start Date

September 1 2008

Last Update

November 23 2009

Active Locations (19)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (19 locations)

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