Solid tumors
Conditions
Interventions
Study group (CIGB-552): The product will be repeated dose administered subcutaneously in 6 dose levels of scale: 1.4 mg, 2.8 mg, 4.7 mg, 7.0 mg, 9.8 mg and 13 mg. The appropriate dose is given three t
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age =18 years. 2) Patients who meet the diagnostic criteria. 3) Values normal blood glucose values according institucionales.l 4) General status ECOG 0-2. 5) Patients who have normal functioning of organs and bone marrow defined by the following parameters: - Haemoglobin = 9 g / L. - Leukocytes = 3 x 109 / L. - Absolute neutrophil count = 1.5 x 109 / L. - Platelet count = 150-250 x 109 / L. - Total bilirubin: Within normal limits as institutional values. - TGP and TGO = 2.5 times the institutional upper limit of normal. - Creatinine: Within normal limits as institutional values. 6) Voluntary patient by signing the informed consent model. 7) Life expectancy greater than 3 months.
Exclusion criteria
Exclusion criteria: 1) Patients who are of childbearing potential not using adequate contraceptive method (IUDs, barrier methods, hormones or tubal ligation) for men (vasectomy, condom use) prior to their inclusion in the study and / or while participating in the clinical trial. 2) Patients with a positive pregnancy test, breastfeeding and postpartum women. 3) Patients suffering from severe allergic diseases. 4) diabetic patients. 5) That have been treated with other biological therapy six months preceding the date of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events of intensity III and IV (Common Toxicity Criteria (Common Toxicity Criteria) (CTC) version 4.0 of the National Cancer Institute USA). Measuring time: after each administration, four weeks after the last administration of the product and at 12 weeks after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - Adverse Events (AE). Measuring time: after each administration, 4 weeks after treatment and 12 weeks after inclusion. . Occurrence of EA (Yes, No) . Name of AE (description of the AE) . Duration of AE (time from start date until end date of AE) . Intensity of AE (Common Toxicity Criteria-CTC) . Gravity (Grave, Not serious) . Result (1. Recovered, 2. Improved, 3. Persists or Squeals) . Attitude respect to EA (1. Temporal interruption, 2. Definitive interruption, 3. Without change, 4. Other) . Causality relationship of AE (11. Very Likely / Safe, 2. Likely 3. Possible, 4. Unlikely 5. Not related, 6. Unknown) . Lot of antitumor peptide (lot identification) - Laboratory tests. Hematology (hemoglobin, Leucogram with differential, hematocrit, platelet count). Measuring time: at baseline, four weeks after treatment and at 12 weeks after inclusion. - Laboratory tests. Biochemistry (transaminases, glucose, bilirubin, alkaline phosphatase, creatinine, total and fractionated proteins). Measuring time: at baseline, four weeks after treatment and at 12 weeks after inclusion. - Laboratory tests. Immunology (CD4 and CD8 levels). Measuring time: at baseline, four weeks after treatment and at 12 weeks after inclusion. Tumor assessment -Objective response (RECIST criteria. Progression, Complete response, Partial response y stable disease, progression). Measuring time: 4 weeks after treatment and 3 months after inclusion. Pharmacokinetic - CIGB peptide plasma concentration-552, only three dose levels 2.8 mg, 4.7 mg y 9.8 mg. Measuring time: at baseline, 10, 20 and 40 minutes and at 1, 1.5, 3, 6, 12 and 24 hours after administration of the product | — |
Countries
Cuba
Contacts
Public ContactMaria Marrero Miragaya
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed