CERVISEG-300-I Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000113
• Date of registration: 17/05/2011
• Primary sponsor: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
• Public title: CERVISEG-300-I Study
• 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.
• Date of first enrolment: 15/01/2006
• Target sample size: 28 - 40
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000113-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: Sequential, scalating doses.

Countries of recruitment

Cuba

Contacts

• Name: Dr. Margarita Solares Asteasuainzarra
• Affiliation: Gyneco-obstetric Hospital “Clodomira Acosta Ferrales”.

• Name: Dr. Idania Baladrón Castrillo
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 65 years
Gender: Female

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).

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.

Secondary Outcome(s)

- 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.

Secondary ID(s)

IG/CIGB-300I/CU/0503

Source(s) of Monetary Support

HeberBiotec S.A. EFFIK Laboratories.

Secondary Sponsor(s)

EFFIK Laboratories.