Safety with interferon in skin carcinomas (SCIENCE study)

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000143
• Date of registration: 30/01/2013
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: Safety with interferon in skin carcinomas (SCIENCE study)
• Scientific title: Multicenter safety study of perilesional application of CIGB-128A in skin carcinomas eyelid with surgical risk and aesthetic implications.
• Date of first enrolment: 31/01/2013
• Target sample size: 12
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000143-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Iraldo Yaquelin Duncan Roberts, MSc. MD. Bello Rivero, PhD
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

• Name: Yaquelin Duncan-Roberts, MSc MD.
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB)

Key inclusion & exclusion 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: 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.

Age minimum: 18 years
Age maximum: N/A (No limit)
Gender: Both

Health Condition(s) or Problem(s) studied

Skin Carcinomas Eyelid (Basal cell and Squamous Cell Ccarcinoma)

Intervention(s)

Perilesional treatment with CIGB-128A, dose of 3.5 MUI, two times per week for 5 weeks.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

IG/IAG/CP/1202

Source(s) of Monetary Support

- Center for Genetic Engineering and Biotechnology (CIGB). Havana - Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable