InCCNM -I

Phase 1

Conditions: Skin basal cell carcinoma, Squamous cells carcinoma.
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Carcinoma
Skin Diseases

Registration Number: RPCEC00000052

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 21

Inclusion Criteria

Age equal or superior to 18 years. Diagnosis of advanced skin epitheliomas, recurring and without response to previous treatments. Lesions of any size, clinical subtype and location. Informed consent given by the patient.

Exclusion Criteria

Pregnant or lactating women. A history of hypersensitivity to interferon or any excipient in the study treatment. Acute or chronic hepatic disease (AST and ALT > 2 times upper limit of normal and/or serum total bilirubin >17 mol/L). Renal failure. Uncompensated heart insufficiency and/or Uncompensated Arterial Hypertension. Serious hematological disorders (serious anemia, sicklemia). Diabetes mellitus. Immune diseases. Mental impairment that may compromise the ability to give informed consent and comply with the study requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients that have adverse reactions (frequency). Time of measurement: During the treatment until week 16.

Secondary Outcome Measures

Name	Time	Method
Size of the lesion (complete response, partial response, stable disease, progression). Time of measurement: in the week 16 of having started the treatment. Time of duration of the clinical response (months). Time of measurement: yearly for 5 years. Cosmetic results (good, regular, bad). Time of measurement: in the week 16 of having started the treatment.