Interferon Combination in basal cell carcinoma (InCarbacel-V 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:

Efficacy study, randomized, controlled, with CIGB-128-A injected perilesional in basal cell carcinoma in different treatment schedules

Secondary indentifying numbers:

IG/IGA/NB/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, Cuba. Ministry of Public Health (MINSAP), Cuba.

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:

05.016.12.B

Principal investigator

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

First name:

Sonia Collazo Caballero, MD, Second Degree Specialist in Dermatology.

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:

Villa Clara, “Arnaldo Milian Castro” Hospital, Jorge L. Tejeda Navarro, MD, Second Degree Specialist in Dermatology. Santiago de Cuba, “Juan Bruno Zayas” Hospital, María Elena Tablada Robinet, MD, First Degree Specialist in Dermatology.

Research ethics committees:

“Hermanos Ameijeiras” Clinical-Surgical Hospital, July 02, 2012. “Arnaldo Milian Castro” Hospital, July 20, 2012. “Juan Bruno Zayas” Hospital, July 23, 2012.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/02/2013

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:

Basal cell carcinoma

Intervention(s):

Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 2 times per week for 4 weeks Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 2 times per week for 6 weeks Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 2 times per week for 8 weeks Control group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 3 times per week for 4 weeks Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 3 times per week for 6 weeks Study group (CIGB-128-A). Perilesional treatment with CIGB-128-A (dose of 10.5 MIU) 3 times per week for 8 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):

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.

Key secondary outcomes:

Clinical response time (Time to reach partial or complete response). Measuring time: weeks 1, 4, 8, 12 and 16. Quality of scarring; Will be evaluated since the clinical standpoint, in patients that respond completely to treatment. Measuring time: at a week 16 and anually for 10 years. Time to recurrence (Time elapsing from the first day provided the absence of neoplasic 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: anually for 10 years. Presence of clinical adverse events (AE) (distribution frequency for the appearance of adverse events (Yes, No), type of event (name of the AE), duration (time between beginning and end of the event), intensity of AE (mild, moderate, severe), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation). Measuring time: during whole treatment. Anti-IFN alpha and gamma antibodies (Patients that develop antibodies (Yes, No) determined by ELISA technique). Measuring time: at baseline and 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. 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.

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:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Factorial

Phase:

Target sample size:

150

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:

Iraldo

Last Name:

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) 208 7379; 208 7421; 208 7465 EXT. 108

Email :

iraldo.bello@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

Last Name:

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) 208 7379; 208 7421; 208 7465 EXT. 108.

Email :

iraldo.bello@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:

RPCEC00000147

Date of Registration in Primary Registry:

2013-02-01

Record Verification Date:

2012-12-27 19:00

Link to the spanish version:

Click here [3]