Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery (IMCX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ioannis Bassukas, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01212562
First received: September 29, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma of the skin.


Condition Intervention Phase
Basal Cell Carcinoma
Procedure: Immunocryosurgery
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Open Label, Phase 3 Study of the Efficacy of Combination of Imiquimod and Cryosurgery in the Treatment of Primary Basal Cell Carcinomas of the Skin

Resource links provided by NLM:


Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
    Basal cell carcinomas of the skin will be treated with immunocryosurgery and the efficacy will be measured 1, 3, 6, and 12 months. Reappearance of the tumor within the primary lesion and 1cm around it will be considered as relapse.


Secondary Outcome Measures:
  • Feasibility and Tolerability of Immunocryosurgery [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood samples with anticoagulant at -20C


Estimated Enrollment: 70
Study Start Date: April 2007
Study Completion Date: August 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Immunocryosurgery
2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application
Procedure: Immunocryosurgery
Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin
Other Name: Aldara

Detailed Description:

Evaluation of efficacy:

  • Number of patient: N=50
  • Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy
  • Exclusion criteria: (1) Size of the tumors >2cm; (2) Distance from the eyelid <1cm; (3)Number of tumors >5

Treatment protocol: Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 10-15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. Persisting erosion will be considered as persistence of the tumor and imiquimod will be continued for another 3 weeks with/or without a cryosurgery session. The patients will be evaluated at 1,3,6,12 months after discontinuation of imiquimod and yearly thereafter for relapse. In case of clinical relapse, it will be confirmed by biopsy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with basal cell carcinoma

Criteria

Inclusion Criteria:

  • Basal cell carcinoma of the skin
  • Size < or = 2cm
  • Number of tumors < or = 5
  • Distance from eyelids, mouth >1cm

Exclusion Criteria:

  • Size >2cm Number of tumors > 5 Distance from eyelids or mouth < or = 1cm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212562

Locations
Greece
Department for Skin and Venereal Diseases, University Hospital
Ioannina, Greece, 45110
Sponsors and Collaborators
University of Ioannina
Investigators
Principal Investigator: Ioannis D Bassukas, Professor Medical School, University of Ioannina
  More Information

Publications:
Responsible Party: Ioannis Bassukas, Associate Professor of Dermatology, University of Ioannina
ClinicalTrials.gov Identifier: NCT01212562     History of Changes
Other Study ID Numbers: 75090409
Study First Received: September 29, 2010
Last Updated: August 31, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Ioannina:
basal cell carcinoma
cryosurgery
imiquimod
immunocryosurgery

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Neoplasms, Squamous Cell
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on April 16, 2014