A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

Phase 2CompletedNCT02013050

Soligenix111 enrolled

Overview

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

111

Conditions

Oral Mucositis

Interventions

SGX942DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT. * Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation. * Planned to receive standard cisplatin chemotherapy administered either weekly or every third week. * Must be able to read and understand informed consent * Adequate birth control methods for the duration of the study Exclusion Criteria: * Current mucositis. * Prior radiation to the head and neck. * Chemotherapy treatment within the previous 12 months. * Tumors of the lips, sinuses, salivary glands or nasopharynx. * Unknown primary tumor. * Stage 4c metastases. * Evidence of significant hepatic, hematologic, or immunologic disease. * Women who are pregnant or breast-feeding.

Locations (1)

Markey Cancer Center-University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Duration of Severe Oral Mucositis (SOM)

Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.

Time frame: 4 weeks after end of therapy

Secondary Outcomes

Residual Severe Oral Mucositis (SOM)

OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.

Time frame: 4 weeks after end of therapy

Duration of Severe Oral Mucositis (SOM)

OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.

Time frame: 4 weeks after end of therapy

Incidence of Clinically Reported, Non-fungal Infections

Time frame: 4 weeks after end of therapy

Percent of Patients With RECIST 1.1 Classification of "Complete Response"

The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows: Target Lesion : Complete Response (CR): All target lesions gone Partial Response (PR): \>30% decrease from Baseline Progressive Disease (PD): \>20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR Non-Target Lesion: Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions

Data from ClinicalTrials.gov

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