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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00756951

Acronym

SCV-07 OM

Enrollment

Registered

2008-09-22

Start date

2008-09-30

Completion date

Unknown

Last updated

2009-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Oral Mucositis

Keywords

SCV-07, Oral Mucositis

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.

Interventions

DRUGPlacebo

Placebo

DRUGSCV-07

0.02 mg/kg

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	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.	7 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026