Diphenhydramine previous to CIGB-300 in cervical carcinoma (CERVISEG-II Study)
- Conditions
- Cervical epidermoid carcinoma, stage IB2-II.
- Registration Number
- RPCEC00000152
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence of severe adverse events (Yes, No). Measuring time: until 24 hours after each CIGB-300 dose.
- Secondary Outcome Measures
Name Time Method