Microinvasive carcinoma of the cervix uteri and high grade cervical lesions.
Conditions
Interventions
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 patient
Sponsors
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
EFFIK Laboratories.
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Cuba
Contacts
Public ContactDr. Margarita Solares Asteasuainzarra
Gyneco-obstetric Hospital “Clodomira Acosta Ferrales”.
Outcome results
None listed