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

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.

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Key information

Conditions

Oral Mucositis Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo

SCV-07

Drug

0.02 mg/kg

Primary outcomes

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
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

Sponsors and collaborators

Lead sponsor

SciClone Pharmaceuticals

Industry

Registry information

Official study 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.

Acronym: SCV-07 OM

Important dates

Study start: 2008
First posted: Sep 22, 2008
Registry last updated: Nov 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed