Skin Carcinomas Eyelid (Basal cell and Squamous Cell Ccarcinoma)
Conditions
Interventions
Perilesional treatment with CIGB-128A, dose of 3.5 MUI, two times per week for 5 weeks.
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Compliance with the diagnostic criteria. 2. Injury Treatment virgins over 1 cm in which no surgical treatment is recommended (by extent of injury or post-surgical cosmetic results) or lesions with incomplete excision with previous surgical treatment or recurrent lesions. 3. Any stage, clinical subtype and skin phototype. 4. Location eyelid. 5. Age equal or higher than 18 years. 6. Voluntariness of the patient by signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Decompensated chronic illness (asthma, diabetes mellitus, heart failure, hypertension, hyperthyroidism). 2. History or symptoms of stroke (ischemic, stroke). 3. History of allergy to any ingredient in the formulation under study. 4. Pregnancy, postpartum or breastfeeding women. 5. Mental incapacity to give consent obvious and act accordingly to the study. 6. Chronic arterial insufficiency reported by patients and verified by physical examination. 7. Severe hematological disorders, checked by complementary laboratory. 8. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient. 9. Patients treated with steroids, immunosuppressants, IFN alpha or gamma in the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe adverse events (Yes, No as classified by the CTCAE v4.02 (Common Terminology Criteria for Adverse Events). Measuring time: in every administration during the 5 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical adverse events (Description of adverse events, event type, body system, identified duration, intensity, outcome, attitude and causation of adverse events). Measuring time: In every administration during the 5 weeks of treatment. Tolerability (subject with adverse events of grade 3 or more according to Common Terminology Criteria for Adverse Events (CTCAE v4.02). Measuring time: In every administration during the 5 weeks of treatment. Laboratory tests (hematologic and biochemical determinations). Measuring time: at baseline, and at week 6. Clinical response (RECIST criteria: Complete response, partial response, stable disease, progressive disease). Measuring time: at baseline, weekly until the 5th week, then at 7, 10, 13 and 16 weeks after starting treatment. Histology: Histology (Absence of tumor, Presence of tumor). Measuring time: at baseline and at 16 weeks. Clinical response time (Time to reach partial or complete response). Measuring time: weekly until the 5th week, then be held in week 7, 10, 13 and 16. Occurrence of relapse: Patients in which appears histologically proven injury in the treated site.Measuring time: annually for 10 years after treatment. Time to recurrence (Time elapsing from the first day provided the absence of neoplastic 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: annually for 10 years after treatment. | — |
Countries
Cuba
Contacts
Public ContactYaquelin Duncan-Roberts, MSc MD.
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed