Biodistribution of CIGB-300 in cervical cancer (CERVIFARM-300-II Study)
- Conditions
- Cervical epidermoid carcinoma, stage IB2-II.
- Registration Number
- RPCEC00000142
- 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method