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)

This study has been completed.
Sponsor:
Information provided by:
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00756951
First received: September 12, 2008
Last updated: November 20, 2009
Last verified: December 2008
  Purpose

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 Intervention Phase
Oral Mucositis
Head and Neck Cancer
Drug: Placebo
Drug: SCV-07
Phase 2

Study Type: 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
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.

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

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. [ Time Frame: 7 Weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 59
Study Start Date: September 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756951

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

Additional Information:
No publications provided

Responsible Party: Israel Rios, MD, SciClone Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00756951     History of Changes
Other Study ID Numbers: SCI-SCV-MUC-P2-001
Study First Received: September 12, 2008
Last Updated: November 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:
SCV-07
Oral Mucositis

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

ClinicalTrials.gov processed this record on July 20, 2014