CERVISEG-300-I 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 Clinical Trial, uncontrolled, dose escalation, the application of IGBC-300 in microinvasive cancer, carcinoma in situ and severe dysplasia of the cervix.

Secondary indentifying numbers:

IG/CIGB-300I/CU/0503

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biothecnology (CIGB)

Source(s) of monetary or material support:

HeberBiotec S.A. EFFIK Laboratories.

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 :

20/09/2005

Reference number:

05-016-05-B

Principal investigator

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

First name:

Margarita Solares Asteasuainzarra, MD.

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, National Center for Toxicology, Carlos Alberto González Delgado. MD.

Research ethics committees:

Gyneco-obstetric Hospital “Clodomira Acosta Ferrales” April 25, 2005. National Center for Toxicology, April 22, 2005.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

15/01/2006

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:

Microinvasive carcinoma of the cervix uteri and high grade cervical lesions.

Intervention(s):

This is a dose-finding study, sequential. Were divided into 4 treatment groups: - Group I: 20 mg daily. - Group II: 100 mg daily. - Group III: 350 mg daily. - Group IV: 700 mg daily. The first patients enrolled will receive the lowest dose (20 mg daily) and according to safety performance will continue with the next dose sequentially. The vial CIGB-300 (containing 350 mg of lyophilized peptide), for application reconstituted in 1 mL water for injection at various dilutions. The product is administered by intralesional injection in a volume not exceeding 1 mL water for injection, in 4 puncture sites within the lesion area. The application frequency is daily for up to 5 days (reducing the number of anticipated applications will be conditional upon the occurrence of adverse events). After 15 days of completion of treatment is performed conization (LEEP).

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):

Security is measured through the following variables: - Adverse events (event number, type, frequency: Yes, No, Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events, Duration: hours, days, months, ratio causality: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death, Treatment indicated: type and dosage of medication, treatment time). - Hematological and biochemical determinations (values ??of hematocrit, platelet count, transaminases, bilirubin, urea, creatinine, glomerular filtration rate). Response time (of the above variables): 24 hours, 15 days and at months 3, 6, 9 and 12 post-treatment.

Key secondary outcomes:

- Histological Evaluation (Stage of injury). - colposcopic evaluation (number, size and scale of colposcopic lesions measurable). - Presence of HPV in biopsies (Yes, No). - surrogate markers of response (molecular parameters such as Angiogenesis and Induction of Apoptosis). Response time (of the above variables): at 15 days of completion of treatment.

Selection criterias

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

Gender:

Female

Minimum age:

18 years

Maximum age:

65 years

Inclusion criteria:

1. Age between 18-65 years inclusive. 2. Histological diagnosis of high grade lesions and microinvasive squamous cell carcinoma of the cervix (stage 1A1 FIGO classification). 3. Presence of residual lesion after the initial punch with diameter = 3 mm, measured by videocolposcopy and corresponding with major changes or invasive stage in the nomenclature of the International Federation of Cervical Pathology and Colposcopy (Barcelona, 2002). 4. Written informed consent and signed by the patient.

Exclusion criteria:

1.Patients meeting any one of the following were excluded from entering the study: Chemotherapy or surgical, ablative, radiant, or immunomodulator treatment, up to 3 months before inclusion. 2.Psychiatric dysfunction. 3.Pregnancy and breast-feeding. 4.Chronic diseases such as asthma, diabetes, epilepsy, autoimmune disease, hypertension, anaemia, acute bacterial or mycotic systemic or genital tract infections, renal, hepatic and cardiovascular disorders. 5.Abnormal laboratory tests. 6.Participation in another therapeutic study within 8 weeks prior to inclusion.

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:

Other

Other design:

Sequential, scalating doses.

Phase:

Target sample size:

28 - 40

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:

Dr. Margarita

Last Name:

Solares Asteasuainzarra

Affiliation:

Gyneco-obstetric Hospital “Clodomira Acosta Ferrales”.

Postal Address:

19 e/8 y 10, Vedado, Plaza de la Revolución.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

(53-7)-8382010

Email :

msolares@infomed.sld.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:

Dr. Idania

Last Name:

Baladrón Castrillo

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave 31 entre 158 y 190, Cubanacán, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465 (53-7)-2087379, 2087421, 2087465, 2085887.

Email :

idania.baladron@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:

RPCEC00000113

Date of Registration in Primary Registry:

2011-05-17

Record Verification Date:

2011-05-06 20:00

Link to the spanish version:

Click here [4]