Interferon Combination in basal cell carcinoma (InCarbacel-V study)

Phase 2

• Conditions: Basal cell carcinoma

• Registration Number: RPCEC00000147
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 150

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.