Skin basal cell carcinoma, Squamous cells carcinoma.
Conditions
Interventions
Intralesional treatment of CIGB-128 to a dose of 3.5 MIU
11 MIU or 21 MIU (according to size of tumor)
three times per week for 3 weeks (ambulatory). In cases with extension of tumor beyond the scope of the needle, infiltration of bone or other cavities, etc.
it will apply the CIGB-128 by intramuscular route IM and/or the treatment will be combined with 1 cycle of chemotherapy every 21 days (4 complete cycles).
Interferon-alpha
Injections, Intramuscular
Drug Therapy
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Ministry of Public Health, CUBA.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients that have adverse reactions (frequency). Time of measurement: During the treatment until week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactYanelda Garcia-Vega
Center for Genetic Engineering and Biotechnology.
Outcome results
None listed