RPCEC00000142
Completed
Phase 1
Biodistribution and pharmacokinetics, safety and therapeutic effect of the CIGB-300 application in the epidermoid carcinoma of the uterine neck stage IB2-II
Center for Genetic Engineering and Biotechnology (CIGB)0 sitesJanuary 18, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cervical epidermoid carcinoma, stage IB2-II.
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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