Safety with interferon in skin carcinomas (SCIENCE study)

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:

Multicenter safety study of perilesional application of CIGB-128A in skin carcinomas eyelid with surgical risk and aesthetic implications.

Secondary indentifying numbers:

IG/IAG/CP/1202

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

- Center for Genetic Engineering and Biotechnology (CIGB). Havana - Ministry of Public Health (MINSAP)

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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

06/11/2012

Reference number:

05.015.12.B.

Principal investigator

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

First name:

Irene Rojas Rondón, MD. Second Degree Specialist in Ophthalmology.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

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:

- Havana, General Hospital "Enrique Cabrera". Alejandro Caiñas Ramos, MD. First Degree Specialist in Ophthalmology. - Havana, Medical – Surgical Research Center (CIMEQ). Yolanda Cruz Gómez. Degree in Biochemistry.

Research ethics committees:

- Cuban Ophthalmology Institute "Ramón Pando Ferrer", June 28, 2012. - General Hospital "Enrique Cabrera", June 27, 2012. - Medical – Surgical Research Center (CIMEQ). Pending.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

31/01/2013

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 Carcinomas Eyelid (Basal cell and Squamous Cell Ccarcinoma)

Intervention(s):

Perilesional treatment with CIGB-128A, dose of 3.5 MUI, two times per week for 5 weeks.

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):

Severe adverse events (Yes, No as classified by the CTCAE v4.02 (Common Terminology Criteria for Adverse Events). Measuring time: in every administration during the 5 weeks of treatment.

Key secondary outcomes:

Clinical adverse events (Description of adverse events, event type, body system, identified duration, intensity, outcome, attitude and causation of adverse events). Measuring time: In every administration during the 5 weeks of treatment. Tolerability (subject with adverse events of grade 3 or more according to Common Terminology Criteria for Adverse Events (CTCAE v4.02). Measuring time: In every administration during the 5 weeks of treatment. Laboratory tests (hematologic and biochemical determinations). Measuring time: at baseline, and at week 6. Clinical response (RECIST criteria: Complete response, partial response, stable disease, progressive disease). Measuring time: at baseline, weekly until the 5th week, then at 7, 10, 13 and 16 weeks after starting treatment. Histology: Histology (Absence of tumor, Presence of tumor). Measuring time: at baseline and at 16 weeks. Clinical response time (Time to reach partial or complete response). Measuring time: weekly until the 5th week, then be held in week 7, 10, 13 and 16. Occurrence of relapse: Patients in which appears histologically proven injury in the treated site.Measuring time: annually for 10 years after treatment. Time to recurrence (Time elapsing from the first day provided the absence of neoplastic cells according to the evaluation histological or clinical (patient refusal to biopsy end or biopsy no useful), until appears an injury histologically demonstrated in the treated site. Measuring time: annually for 10 years after 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:

N/A (No limit)

Inclusion criteria:

1. Compliance with the diagnostic criteria. 2. Injury Treatment virgins over 1 cm in which no surgical treatment is recommended (by extent of injury or post-surgical cosmetic results) or lesions with incomplete excision with previous surgical treatment or recurrent lesions. 3. Any stage, clinical subtype and skin phototype. 4. Location eyelid. 5. Age equal or higher than 18 years. 6. Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1. Decompensated chronic illness (asthma, diabetes mellitus, heart failure, hypertension, hyperthyroidism). 2. History or symptoms of stroke (ischemic, stroke). 3. History of allergy to any ingredient in the formulation under study. 4. Pregnancy, postpartum or breastfeeding women. 5. Mental incapacity to give consent obvious and act accordingly to the study. 6. Chronic arterial insufficiency reported by patients and verified by physical examination. 7. Severe hematological disorders, checked by complementary laboratory. 8. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient. 9. Patients treated with steroids, immunosuppressants, IFN alpha or gamma in the last three months.

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:

Yaquelin

Last Name:

Duncan-Roberts, MSc MD.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 / 158 and 190, Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+53 (7) 2087379; 2087465 ext 108.

Email :

yaquelin.duncan@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:

Iraldo Yaquelin

Last Name:

Duncan Roberts, MSc. MD. Bello Rivero, PhD

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 / 158 and 190, Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+53 (7) 2087379; 2087465 ext 108.

Email :

iraldo.bello@cigb.edu.cu [3]

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:

RPCEC00000143

Date of Registration in Primary Registry:

2013-01-30

Record Verification Date:

2013-01-08 19:00

Link to the spanish version:

Click here [4]