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

This study has been terminated.
(safety issues)
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01808950
First received: March 5, 2013
Last updated: May 12, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Nodular Basal Cell Carcinoma
Drug: 0.06% Resiquimod Gel - A
Drug: 0.06% Resiquimod Gel - B
Drug: 0.06% Resiquimod Gel - C
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)

Further study details as provided by Spirig Pharma Ltd.:

Primary Outcome Measures:
  • Histological Cure Rate [ Time Frame: 8 weeks after a maximal treatment period of 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete Clinical Clearance Rate [ Time Frame: 8 weeks after the 4 weeks treatment period ] [ Designated as safety issue: No ]
  • Evaluation of Local Tolerability by Means of 5-point Scales [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: February 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.06% Resiquimod Gel - A
  • 60 mg gel
  • Once daily prior to normal sleeping hours
  • 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
Drug: 0.06% Resiquimod Gel - A
single 60mg dose
Other Name: CD11301
Experimental: 0.06% Resiquimod Gel - B
  • 100 mg gel
  • Once daily prior to normal sleeping hours
  • 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
Drug: 0.06% Resiquimod Gel - B
single 100mg dose
Other Name: CD11301
Experimental: 0.06% Resiquimod Gel - C
  • 100 mg gel
  • Once daily prior to normal sleeping hours
  • 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
  • The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
Drug: 0.06% Resiquimod Gel - C
shave biopsy of BCC followed by single 100mg dose
Other Name: CD11301

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01808950

Locations
Germany
Hauttumorcentrum Charité (HTCC)
Berlin, Germany
Switzerland
Universitaetsspital
Zurich, Switzerland
Sponsors and Collaborators
Spirig Pharma Ltd.
Investigators
Principal Investigator: R Dummer, PrMD Clinical Dermatolgy Zurich
  More Information

Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01808950     History of Changes
Other Study ID Numbers: SP848-nBCC-1104 
Study First Received: March 5, 2013
Results First Received: December 3, 2015
Last Updated: May 12, 2016
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on September 27, 2016