Basal cell carcinoma
Conditions
Interventions
Perilesional treatment with HeberPAG, three time a week, for 3 weeks, doses from 3.5 to 10.0 MIU, as outpatient.
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 of any size, clinical subtype, localization 4. Non recurrent or recurrent lesions. 5. Without or with 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/dL in women and 11 g/dL 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 |
|---|---|
| Clinic Response (RECIST. Complete Response, Partial Response, Stable Disease, Progression Disease). Measuring time: at baseline and at week 16 (tangible and residual injury) after starting the treatment. Dermatocopy (Absence of tumour cells, Presence of tumour cells). Measuring time: at baseline and at week 16. Histology (Absence of tumor, Presence of tumor). Measuring time: at baseline and at week 16. 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: at each HebePAG administration. Anti-IFN alpha and gamma antibodies (patients that develop antibodies (Yes, No), by ELISA). Measuring time: at baseline and at week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of scarring; Will be evaluated since the clinical standpoint, in patients that respond completely to treatment. Measuring time: at baseline and at week 16. Presence of recurrence. Defined by the appearance of a tumor lesion with the same histological type to that treated, in the same previously affected anatomic area. Measuring time: until ten years after treatment. | — |
Countries
Cuba
Contacts
Public ContactIraldo Bello Rivero
Center for Genetic Engineering and Biotechnology
Outcome results
None listed