Cervical epidermoid carcinoma, stage IB2-II.
Conditions
Interventions
Study group (CIGB-300, 70 mg): CIGB-300 + CRT CIGB-300: Doses of 70 mg resuspended in 1 ml of water for injection, applied by intratumor route once per day, during 5 days, in one injection site, in th
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 inferior to 19 or superior to 30. 3. Pregnancy or nursing. 4. Decompensate chronic disease (arterial hypertension, diabetes mellitus, chronic renal disease, cardiac insufficiency,hyperthyroidism, malignant neoplasia, epilepsy, severe mental depression). 5. Patients with previous diagnosis of coagulation dysfunctions and other decompensate chronic hematopahies (hemophilia, leukemia, among other). 6. Clinical laboratory values outside their 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, or Bronchitis and persistent Bronchial Asthma. 9. Febrile illness (temperature >37.8°C) at the moment 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 their informed consent or to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of severe adverse events (Yes, No). Measuring time: until 24 hours after each CIGB-300 dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables: Clinical adverse events (AE). Measuring time: until 24 hours after each CIGB-300 administration. Then, patients will be followed for safety during chemo-radiotherapy and each three months until one year after this. - Presence of AE (Yes, No), - Type of AE (Name of the AE), - Duration of the AE (time from appearance to end of the event), - Intensity of the AE (mild, moderate, severe), - Relation of causality of the AE (remote, possible, probable, very probable), - Result of the 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 mm Hg and respiratory rate in breaths per minute). Measuring time: before CIGB-300, at 30 minutes, 1h, 1h, 2h, 3h, 4h, 12h and 24h after injection. Laboratory tests (hemoglobin (g/L), hematocrit (L/L), leucocyte counts (x109/L), platelet count (x109/L), globular sedimentation rate (mm/h), glucemy (mmol/L), serum creatinine (?mol/L), AST (IU/L), ALT (IU/L). Measuring time: Before and 21 days after CIGB-300 treatment. Later weekly during chemo-radiotherapy and each three months during a one-year follow-up. Therapeutic response: Clinical-colposcopical evaluation: Size of the tumoral lesion (diameters and area of the tumor surface) captured by digital picture and measured using MADIP software. Measuring time: Before and 24 hours after the last CIGB-300 dose and whenever it is required by safety requirements. Biweekly during CRT and quarterly until complete 1 year after CRT. Imagenological evaluation of the lesion: Evaluation of the tumor size using Abdominal and transvaginal ultrasonography, CT scans, MRI, according to the evaluation criteria for solid tumors (RECIST). Measuring time: MRI: Before CIGB-300 treatment, 21 days after this, and after CRT quarterly until to complete 1 year. CT scans and abdom | — |
Countries
Cuba
Contacts
Public ContactLidia Idania Idrian María Yaleisys González-Méndez, MD Baladron-Castrillo, MD García-García, MSc Dolores-Castro, MD Rosales-Pantoja, BSc
Center for Genetic Engineering and Biotechnology
Outcome results
None listed