InCCNM -I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000052
• Date of registration: 24/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: InCCNM -I
• Scientific title: Case treatment of: Intralesional application of the CIGB-128 in the treatment of the advanced skin epitheliomas, recurrent or without response to previous treatments.
• Date of first enrolment: 05/08/2002
• Target sample size: 21
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000052-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: MSc. Yanelda García-Vega
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB).

• Name: Yanelda Garcia-Vega
• Affiliation: Center for Genetic Engineering and Biotechnology.

Key inclusion & exclusion 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.

Age minimum: 18 years
Age maximum: No limit
Gender: Both

Health Condition(s) or Problem(s) studied

Skin basal cell carcinoma, Squamous cells carcinoma.

Intervention(s)

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).

Primary Outcome(s)

Proportion of patients that have adverse reactions (frequency). Time of measurement: During the treatment until week 16.

Secondary Outcome(s)

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.

Secondary ID(s)

IG/IAI-IGI/NNM/0101

Source(s) of Monetary Support

Heber Biotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA.