Solid tumors refractory to oncospecific treatment.
Conditions
Interventions
It CIGB-300 administered intravenously using a dose-finding design sequentially, based on a continuous reallocation method of dose escalation. The doses to be studied will be: - 0.2 mg/kg - 0.4 mg/kg
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Ministry of Public Health, Cuba.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of tumor response, if necessary through imaging tests (tumor diameter). Measuring time: 45 days after treatment ended, and every 3 months until the year into the study. | — |
Primary
| Measure | Time frame |
|---|---|
| Adverse events (Event number; Type; Frequency: Yes, No; Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related to adverse events; Duration: days or hours; Causal relationship: remote, possible, likely, very likely; Result: Fully resolved Resolved with sequelae, in improving conditions, conditions still present and unchanged, worsening, Death; Treatment indicated: type and dosage of medication, treatment time). Measuring time: 30 minutes and hour, 2, 4, 8 and 12 hours after administration of each dose of CIGB-300. Percent maximum uptake (maximum percentage is the fraction of injected activity that is captured or incorporated by an organ or tumor and is determined as: Activity (tmax) * 100/Actividad Injected, where tmax is the time it reaches the maximum incorporation). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Fraction of incorporation (is the total fraction of injected activity that is incorporated into an organ or tumor and is determined as total activity incorporated / injected activity). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Fraction of elimination (total fraction of injected activity that is eliminated by an organ or tumor and is determined as total activity eliminated / injected activity). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 12, 16 and 24, after administration of the 1st and 5th cycle CIGB-300, depending on the dose. Average time biological uptake (is the average time that the activity taken to an organ or tumor increases to half of its value and is determined as: ln (2)/k, where k is the constant of biological incorporation). Measuring time: in the first 5, 15 and 30 minutes later in the hours 1, 2, 3, 5, 7, 1 | — |
Countries
Cuba
Contacts
Public ContactDr. Lidia González Méndez
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed