InCCNM -I

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

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.

Secondary indentifying numbers:

IG/IAI-IGI/NNM/0101

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Lorenzo

Last name:

Anasagasti Angulo

Medical Specialty :

Specialist in Oncology and Radiobiology

Affiliation:

National Institute of Oncology and Radiobiology

Postal address:

Calle 29 esquina a F , Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78382578

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

National Institute of Oncology and Radiobiology (INOR), April 19th, 2002.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

05/08/2002

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Skin basal cell carcinoma, Squamous cells carcinoma.

Health condition(s) code:

Carcinoma, Basal Cell

Skin Neoplasms

Carcinoma, Squamous Cell

Neoplasms, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Carcinoma

Skin Diseases

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).

Intervention code:

Interferon-alpha

Interferon-gamma

Interferons

Injections, Intralesional

Injections, Intramuscular

Drug Therapy

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yanelda

Last Name:

Garcia-Vega

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2087377

Email :

yanelda.garcia@cigb.edu.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Yanelda

Last Name:

García-Vega

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB).

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2087377

Email :

yanelda.garcia@cigb.edu.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000052

Date of Registration in Primary Registry:

2010-12-24

Record Verification Date:

2008-03-12 20:00

Link to the spanish version:

Click here [3]