Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma

Phase 2TerminatedNCT01808950

Spirig Pharma Ltd.4 enrolled

Overview

The primary objective is the observation and description of the preliminary efficacy of resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of patients.

efficacy assessments: * Histopathological findings based on the biopsies of the primary tumor location and the tissue excision at the end of trial (histological cure). * Description of the clinical-therapeutic effect of resiquimod on nBCC (nodular-basal cell carcinoma) by visual inspection (clinical evaluation of treatment area and assessment of complete clinical clearance) * RNA-analysis (analysis of gene expressions for cytokines, cytotoxic and apoptotic signals) * Investigator's global judgment of efficacy by means of a 7-point scale Safety assessments: * Evaluation of Adverse Events (AEs) and Serious Adverse Events (SAEs) * Evaluation of local tolerability (local skin reactions as erythema, edema, erosion/ulceration, exsudate, dryness, encrustation) by means of symptom scoring scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe). * Evaluation of systemic tolerability \[hematology (erythrocytes, leucocytes including neutrophils, hemoglobin, hematocrit, thrombocytes), blood chemistry (alkaline phosphatase, bilirubin, aspartate transaminase (ASAT), alanine transaminase (ALAT), serum creatinine), vital signs\]. The thresholds concerning laboratory abnormalities that determine patient's discontinuation from trial were predefined upfront. * Evaluation of the number of patients withdrawn from the trial * Investigator's global judgment of tolerability by means of a 6-point scale * Photographic documentation of the treatment area Exploratory parameter: * C-reactive protein (CRP) * Interferon-alpha, interleukin-6, interleukin-12, interferon-gamma, TNF-alpha (up-regulation of gene expression) * Immunohistochemistry and characterization of cell types (CD8, T-cells, macrophages, dendritic cells) * In addition, blood serum samples will be preserved and frozen for later tests that will be specified to the patients. The preserved material will be stored for a maximum of 2 years.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Nodular Basal Cell Carcinoma

Interventions

0.06% Resiquimod Gel - ADRUG

single 60mg dose

0.06% Resiquimod Gel - BDRUG

single 100mg dose

0.06% Resiquimod Gel - CDRUG

shave biopsy of BCC followed by single 100mg dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed consent form. * Male or non-pregnant, non-lactating female, ≥ 18 years. * Must have a previously untreated, histologically confirmed nBCC on head, neck, trunk or arms. * nBCC must not be larger than 20 mm in diameter and must be less than 5 mm in depth. * Willing and able to participate in the trial as an outpatient and comply with all trial requirements. Exclusion Criteria: * nBCC located close to or at mouth or eyes. * Patients who have had an organ transplant. * Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV), known thyroid abnormalities, known depression. * An open wound or an infection in treatment area. * Dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments. * Evidence of an active infection or systemic cancer. * Flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial. * Known allergy or hypersensitivity to any of the trial gel ingredients. * Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease). * Current alcohol abuse or chemical dependency as assessed by the investigator. * Patient who is detained or committed to an institution by a law court or by legal authorities. * Participation in another clinical trial within one month before start of the trial.

Locations (2)

Hauttumorcentrum Charité (HTCC)

Berlin, Germany

Universitaetsspital

Zurich, Switzerland

Outcomes

Primary Outcomes

Histological Cure Rate

Time frame: 8 weeks after a maximal treatment period of 4 weeks

Secondary Outcomes

Complete Clinical Clearance Rate

Time frame: 8 weeks after the 4 weeks treatment period

Evaluation of Local Tolerability by Means of 5-point Scales

local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).

Time frame: up to 12 weeks

Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs

Time frame: up to 12 weeks

Global Judgment of Tolerability by Investigator by Means of a 6-point Scale

Time frame: 8 weeks after a maximal treatment period of 4 weeks

Data from ClinicalTrials.gov

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