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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756951
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : November 23, 2009
Information provided by:
SciClone Pharmaceuticals

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 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 59 participants
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 : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Drug: 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

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756951

  Show 19 Study Locations
Sponsors and Collaborators
SciClone Pharmaceuticals
Study Director: Israel Rios, MD SciClone Pharmaceuticals

Additional Information:
Responsible Party: Israel Rios, MD, SciClone Pharmaceuticals, Inc. Identifier: NCT00756951     History of Changes
Other Study ID Numbers: SCI-SCV-MUC-P2-001
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: December 2008

Keywords provided by SciClone Pharmaceuticals:
Oral Mucositis

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases