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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Oral Mucositis, Head and Neck Cancer

Thank you

Trial Information

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.


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

Type of Study:

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

Outcome Measure:

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.

Outcome Time Frame:

7 Weeks

Safety Issue:

Yes

Principal Investigator

Israel Rios, MD

Investigator Role:

Study Director

Investigator Affiliation:

SciClone Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SCI-SCV-MUC-P2-001

NCT ID:

NCT00756951

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Oral Mucositis
  • Head and Neck Cancer
  • SCV-07
  • Oral Mucositis
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Medical College of WisconsinMilwaukee, Wisconsin  53226
Whittingham Cancer CenterNorwalk, Connecticut  06856
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Beth Israel Medical CenterNew York, New York  10003
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Illinois at ChicagoChicago, Illinois  60612
Montefiore Medical CenterBronx, New York  10467-2490
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Temple UniversityPhiladelphia, Pennsylvania  19140
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Ohio State University Medical CenterColumbus, Ohio  43210
Mid Dakota ClinicBismarck, North Dakota  58501
Karmanos Cancer InstituteDetroit, Michigan  48201
The Nebraska Medical CenterOmaha, Nebraska  68198
St Luke's Hospital & Health NetworkBethlehem, Pennsylvania  18015
Helen F Graham Cancer CenterNewark, Delaware  19713
Washington University in St LouisSt Louis, Missouri  63110