Squamous cell carcinoma interferons (CECIN 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:

Open study, single center, perilesional and intralesional application of HeberPAG ® in squamous carcinomas of the skin, stage I and II

Secondary indentifying numbers:

IG/AGI/NE/0901

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, 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 :

26/02/2010

Reference number:

05.028.09.B

Principal investigator

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

First name:

Manuel Salazar Sedano, MD. First 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:

Camagüey, “Amalia Simoni” Clinical-Surgical Hospital, Idalmis Campollo Rodríguez MD, First Degree Specialist in Dermatology.

Research ethics committees:

“Hermanos Ameijeiras” Clinical-Surgical Hospital, July 6th, 2009. “Amalia Simoni” Clinical-Surgical Hospital, April 21, 2010.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

01/06/2010

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:

Squamous cells carcinoma

Intervention(s):

Perilesional and Intralesional treatment of HeberPAG, dose of 11.5 MUI, three times per week for 3 weeks, 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):

Clinical Response (size of the lesion- tangible and residual injury). Measuring time: at baseline and at week 16 after starting the treatment. Histological characteristics (Absence of tumor, Presence of tumor). Measuring time: at baseline and at week 16 after starting the treatment. Clinical response time(in weeks). Measuring time: Weeks 1, 2, 3 4, 6, 8, 10, 12, 14 and 16.

Key secondary outcomes:

Quality of scarring (Good, Regular or Bad). Measuring time: Will be evaluated since the clinical standpoint, in patients that respond completely to treatment, on the 16 week of having started the treatment and during follow-up, which will be three months during the 1st year, half in the 2nd and 3rd and annually in the 4th and 5th year. Scarring Good: • Color: normocromía, slight or slight hypochromia hyperchromia. • Volume: flat lesion, slight slight atrophy or hypertrophy. • Sensitivity: normal. Regular Scarring: • Color: moderate or moderate hypochromia hyperchromia • Volume: moderate moderate hypertrophy or atrophy. • Sensitivity: Light to moderate hyperesthesia, hypoesthesia, spontaneous pain or itching. Scarring Bad: • Color: hyperchromia severe, or severe hypochromia achromia. • Volume: severe hypertrophy, keloid or severe atrophy. • Sensitivity: Severe hyperesthesia, hypoesthesia, anesthesia, spontaneous pain or pruritus. 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: Months 3, 6, 9, 12, 18, 24, 48, 60. Severe adverse events (Yes, No) Measuring time: At each dose during the 3 weeks of treatment. Anti-IFN alpha and gamma antibodies by ELISA (Patients that develop antibodies (Yes, No)). Measuring time: before treatment and on the 16 week 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:

N/A (No limit)

Inclusion criteria:

1. Clinical and histological diagnosis of ECC*. 2. > 18 years of age. 3. Lesions between 1.5 - 5.0 cm. 4. Invasive clinical subtype, from any location and photo type of skin. * If the patient has more than one lesion, the largest that falls within the range of inclusion (1.5 - 5.0 cm) will be treated.

Exclusion criteria:

1. Pregnancy, postpartum or breastfeeding women. 2. Hypersensitivity to HeberPAG or other preparations used in the study. 3. Intraepithelial clinical subtypes or "in situ" of the ECC (Actinic keratosis, Bowen's Disease / Erythroplasia of Queirat, keratoacanthoma). 4. Uncompensated severe arterial hypertension proven by clinical examination. 5. Chronic arterial insufficiency reported by patients and verified by physical examination 6. Diabetes mellitus, Sickle-cell disease. 7. Severe hematological disorders, checked by complementary laboratory measurements (hemoglobin <10 g/l in women and 11 g/l in men). 8. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient and verified by clinical and laboratory examinations (AST, ALT, alkaline phosphatase, bilirubin, creatinine, serum amylase). 9. Very committed general condition (cachexia, severe debilitating disease patients). 10. Patients treated with steroids, immunosuppressants, IFN alpha or gamma in the last three months. 11. Patients receiving other specific cancer treatment at the time of inclusion. 12. Other malignancies and immunological diseases reported by the patient and confirmed by clinical examination. 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:

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, 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) 208 7379; 208 7421; 208 7465 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:

Bello-Rivero, PhD. Duncan-Roberts, 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) 208 7379; 208 7421; 208 7465 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:

RPCEC00000144

Date of Registration in Primary Registry:

2013-02-01

Record Verification Date:

2013-01-08 19:00

Link to the spanish version:

Click here [4]