Interferon Combination in basal cell carcinoma (InCarbacel-IV 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.

Acronym of Public Title:

InCarbacel-IV study

Scientific title:

Phase IV study of national extension of HeberPAG use in patients with basal cell carcinoma to assess effectiveness and safety at the population level

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).

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:

Sonia

Last name:

Collazo Caballero

Medical Specialty :

Second Degree Specialist in Dermatology.

Affiliation:

“Hermanos Ameijeiras” Clinical-Surgical Hospital

Postal address:

San Lázaro No. 701 esquina a Belascoaín.

City:

Havana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email address:

email@not.entered

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:

Santiago de Cuba, Hospital “Juan Bruno Zayas”, Adelina Baltazar Green, MD, Second Degree Specialist in Dermatology.

Holguín, Hospital “Vladimir Ilich Lenin”, Raúl Santiesteban Batista, MD, First Degree Specialist in Oncology.

Holguín, Clinic “Miguel Gutiérrez Ardaya”, Katherine Batista Ochoa, MD, First Degree Specialist in Dermatology.

Holguín, Clinic "José Ávila Serrano", Raúl Bermúdez Pino, MD, First Degree Specialist in Dermatology.

Mayabeque, Clinic “Luis Li Trejent”, Doraiquis Acosta, MD, First Degree Specialist in Dermatology.

Havana, Hospital “Enrique Cabrera”, Clarivel Saavedra, MD, Second Degree Specialist in Dermatology.

Research ethics committees:

“Hermanos Ameijeiras” Clinical-Surgical Hospital, Havana, July 2nd, 2012.

Hospital “Juan Bruno Zayas”, Santiago de Cuba, June 18, 2012.

Hospital “Vladimir Ilich Lenin”, Holguin, November 2nd, 2012.

Clinic “Miguel Gutiérrez Ardaya”, Holguín, November 16, 2012.

Clinic "José Ávila Serrano", Holguín, June 30, 2012.

Clinic “Luis Li Trejent”, Mayabeque, November 1st, 2012.

Hospital “Enrique Cabrera”, Havana, June 2nd, 2012.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

26/12/2012

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):

Perilesional treatment with HeberPAG, three time a week, for 3 weeks, doses from 3.5 to 10.0 MIU, as outpatient.

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):

Clinic Response (RECIST. Complete Response, Partial Response, Stable Disease, Progression Disease). Measuring time: at baseline and at week 16 (tangible and residual injury) after starting the treatment. Dermatocopy (Absence of tumour cells, Presence of tumour cells). Measuring time: at baseline and at week 16. Histology (Absence of tumor, Presence of tumor). Measuring time: at baseline and at week 16. 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: at each HebePAG administration. Anti-IFN alpha and gamma antibodies (patients that develop antibodies (Yes, No), by ELISA). Measuring time: at baseline and at week 16.

Key secondary outcomes:

Quality of scarring; Will be evaluated since the clinical standpoint, in patients that respond completely to treatment. Measuring time: at baseline and at week 16. Presence of recurrence. Defined by the appearance of a tumor lesion with the same histological type to that treated, in the same previously affected anatomic area. Measuring time: until ten 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:

None

Inclusion criteria:

1. Clinical and histological diagnosis of BCC. 2. > 18 years of age. 3. Lesions of any size, clinical subtype, localization 4. Non recurrent or recurrent lesions. 5. Without or with 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/dL in women and 11 g/dL 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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

200

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

Specialty:

PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

Clinical Investigation Department, Ave. 134 between 23 and 25, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6332

Telephone:

+ (53-7) 2087379; 2087421; 2087465 EXT.108

Email :

iraldo.bello@cigb.edu.cu

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

Specialty:

PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology

Postal Address:

Clinical Investigation Department, Ave. 134 between 23 and 25, Cubanacán, Playa.

City:

Havana

País:

Cuba

Zip Code:

6332

Telephone:

+ (53-7) 2087379; 2087421; 2087465 EXT.108

Email :

iraldo.bello@cigb.edu.cu

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).

Unique ID number:

RPCEC00000164

Date of Registration in Primary Registry:

22/08/2013

Record Verification Date:

2013/08/22

Next update date:

2014/08/22

Link to the spanish version:

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Interferon Combination in basal cell carcinoma (InCarbacel-IV study)

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