RPCEC00000052
Completed
Phase 1
Case treatment of: Intralesional application of the CIGB-128 in the treatment of the advanced skin epitheliomas, recurrent or without response to previous treatments.
Center for Genetic Engineering and Biotechnology (CIGB)0 sites21 target enrollmentDecember 24, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Skin basal cell carcinoma, Squamous cells carcinoma.
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Enrollment
- 21
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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