Cervical epidermoid carcinoma, stage IB2-II.
Conditions
Interventions
Study group (CIGB-300, 35 mg): Doses of 35 mg resuspended in 1 ml of water for injection, applied by intratumor route in 3 cycles of daily applications for 3 days in the weeks 1, 3 and 5, respectively
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Ministry of Public Health, Cuba
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Clinical, imagenological and histological diagnosis of stage IB-II epidermoid cervical cancer. 2. Age between 18-75 years, both included. 3. Written informed consent by the patient. 4. Clinical laboratory parameters within normal limits. 5. General health index from 0 to 2, according to WHO classification. 6. Life expectation of more than 1 year.
Exclusion criteria
Exclusion criteria: 1. To have received surgical, ablative or immunomodulatory treatment during the 30 days before inclusion. 2. Body Mass Index lower than 19 or greater than 30. 3. Pregnancy or nursing. 4. Other decompensate chronic disease (arterial hypertension, diabetes mellitus, chronic renal disease, cardiac insufficiency,hyperthyroidism, malignant neoplasia, epilepsy, severe mental depression). 5. Previous diagnosis of dysfunction of coagulation and other decompensate chronic hematopahies (hemophilia, leukemia, among other). 6. Clinical laboratory values outside normal ranges before the treatment. 7. Referred Immunosuppressor disease and current ingestion of immunosuppressor / immunomodulating drugs (including steroids) 30 days previous the study. 8. Autoimmune disorders (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Type 1 Diabetes Mellitus, etc.) and severe allergic antecedents such as Urticaria, Dermatitis, Bronchitis and persistent Bronchial Asthma. 9. Febrile illness (temperature >37.8°C) at time or 24 hours before administration of the product or acute infectious disease suspected by clinical examination. 10. Diseases that compromise the state of the patient's conscience or their possibility to give informed consent or collaborate in the trial. 11. Tumoral extensive necrosis that prevent the application of the product as indicate the protocol. 12. To be included in another clinical trial or to have been included in a previous trial the last 8 weeks prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biodistribution and Pharmacokinetics Biodistribution (Body gammagraphy. Distribution of the radiolabeled peptide in tumor and main source organs). Measuring time: 10 min, 1h, 2h, 4h, 8h, 12h y 24h after the first administration. Pharmacokinetic studies in serum, whole blood and urine (measurement of activity, and quantification of CIGB-300 serum by ELISA and HPLC). Measuring time: Immediately, 5 min, 15 min, 30 min, 1h, 2h, 4h, 8h, 12h y 24h after the first dose. The urine will be collected at intervals during this sampling period to determine the excreted magnitude and renal clearance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables: Presence of severe adverse events (Yes, No). Measuring time: at each administration. Presence of clinical Adverse Events (AE). Measuring time: at each administration. - Appearance of AE (Yes, No) - Type of AE (name of the AE) - Duration of AE (time from appearance to 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). Vital signs (body temperature in Celsius degrees, heart rate in beats per minute, blood pressure in mmHg and respiratory rate in breaths per minute). Measuring time: before each dose, at 30min, 1h, 1h, 2h, 3h, 4h and 12h after each dose. Laboratory tests hemoglobin, white blood cells counts, globular sedimentation rate, coagulation parameters, glucemy, transaminases, bilirubin, alkaline phosphatase, urea, creatinine). Measuring time: Before and 24 hours after each CIGB-300 cycle. Afterwards weekly during chemo-radiotherapy and each three months during a one-year follow-up. Histamine plasmatic levels (ELISA techniques). Measuring time: At baseline, 5min, 15min,30min and 60min after the first dose. Therapeutic response: Clinical colposcopic evaluation (Size of the tumoral lesion in diameters and area of the tumor surface captured by digital picture and measured using MADIP software). Measuring time: Before and 24 hours after each cycle and whenever it is required by safety requirements. Biweekly during CRT and quarterly until complete 1 year after CRT. Imagenological evaluation (Tumor size using abdominal and transvaginal ultrasonography, CT scans, MRI, according to the evaluation criteria for solid tumors-RECIST). Measuring time: Before CIGB-300 treatment. After the last CIGB-300 cycle (week 5). After the whole treatment quarterly until complete 1 year. Biological respon | — |
Countries
Cuba
Contacts
Public ContactIdrian García-García, MSc
Center for Genetic Engineering and Biotechnology (CIGB)
Outcome results
None listed