RPCEC00000112
Recruiting
Phase 1
Safety clinical trial and pharmacological evaluation of intravenous administration of CIGB-300 in patients with solid tumors refractory to oncospecific treatment.
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 sitesMay 16, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid tumors refractory to oncospecific treatment.
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histological diagnosis of a solid tumor refractory to treatment oncospecific. 2\) That the patient did not receive more than 2 lines of chemotherapy. 3\) last cycle of chemotherapy 4 to 8 weeks after treatment ends oncospecific. 4\) Age between 18\-75 years inclusive. 5\) Written consent from the patient.
Exclusion Criteria
- •1\) Pregnancy and lactation 2\) decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy, severe mental depression). 3\) moderate or severe systemic infections that interfere with patient evaluation. 4\) Patients with previous diagnosis of bleeding disorders and other chronic decompensated hematopatías (hemophilia, leukemia, etc.). 5\) Values ??in clinical laboratory evaluations were normal limits prior to the start of treatment: 6\) referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory properties. 7\) Autoimmune diseases (lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and previous severe allergic urticaria, dermatitis, bronchitis, bronchial asthma and persistent. 8\) diseases that compromise the patient's consciousness or his ability to give informed consent or cooperate in the trial. 9\) Have been included in another trial in the last 8 weeks.
Outcomes
Primary Outcomes
Not specified
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