Basal cell carcinoma
Conditions
Interventions
Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 2 times per week for 4 weeks Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 2 t
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Clinical and histological diagnosis of BCC. 2. > 18 years of age. 3. Lesions between 1.5 cm2 - 10.0 cm2. 4. Lesions of any subtype, localization and size. 5. Non recurrent lesion. 6. Without previous specific treatments.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, postpartum or breastfeeding women. 2. Hypersensitivity to interferon or other preparations used in the study. 3. Any uncompensated chronic disease corroborated by clinical examination. 4. Chronic cardiac, respiratory or arterial insufficiency reported by patients and verified by physical examination. 5. Antecedents of non-compensated transitory cerebral ischemia. 6. Medical non-treatable seizures. 7. Signs of medullar affectation. 8. Severe disorders of coagulation. 9. Sicklemia or drepanocityc anemia. 10. Severe hematological disorders, checked by complementary laboratory (hemoglobin <10 g/l in women and 11 g/l in men). 11. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient and verified by clinical examination and laboratory (AST, ALT, alkaline phosphatase, bilirubin, creatinine, serum amylase). 12. General condition very committed (cachexia, severe debilitating disease patients). 13. Severe psychiatric disorders or other constraints that prevent the patient's consent or hinder evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (Size of the lesion. RECIST criteria. Complete Response (CR); Partial Response (PR); Stable Disease (SD) and Progression Disease (PD)). Measuring time: at baseline and at week 16 after starting the treatment. Dermatocopy (Characteristics of lesions by dermatoscopic imagines. The response will be declared as: absence of tumor cells or presence of tumor cells). Measuring time: at baseline and at week 16. Histology (Histological characteristics of lesions. Will be classified in the following categories: Absence of tumor: Without histological evidence of neoplastic cells; Presence of tumor: Histological evidence of neoplastic cells). Measuring time: at baseline and at week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response time (Time to reach partial or complete response). Measuring time: weeks 1, 4, 8, 12 and 16. Quality of scarring; Will be evaluated since the clinical standpoint, in patients that respond completely to treatment. Measuring time: at a week 16 and anually for 10 years. Time to recurrence (Time elapsing from the first day provided the absence of neoplasic cells according to the evaluation histological or clinical (patient refusal to biopsy end or biopsy no useful), until appears an injury histologically demonstrated in the treated site). Measuring time: anually for 10 years. Presence of clinical adverse events (AE) (distribution frequency for the appearance of adverse events (Yes, No), type of event (name of the AE), duration (time between beginning and end of the event), intensity of AE (mild, moderate, severe), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: during whole treatment. Anti-IFN alpha and gamma antibodies (Patients that develop antibodies (Yes, No) determined by ELISA technique). Measuring time: at baseline and after treatment. | — |
Countries
Cuba
Contacts
Public ContactIraldo Bello-Rivero, PhD
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed