Solid tumors Solid tumors
Conditions
Interventions
In Phase I, dose escalation will begin at the lowest dose level and will escalate to the next level when the first patient at the lowest dose level has completed the first 14 doses of treatment or at
Interleukin-2
Interleukins
Cytokines
Administration, Intravenous
mutein no alfa of IL-2
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Patients who give their written informed consent to participate. 3. Patients of either sex aged over 18 years. 4. Patients generally = 2 state (as ECOG). 5. Patients with a life expectancy of at least 6 months. 6. Patients having functioning of organs and bone marrow under pre-defined parameters.
Exclusion criteria
Exclusion criteria: 1. Patients of childbearing age who are not using an appropriate method of contraception prior to inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). If male (vasectomy, condom use). 2. Pregnant or lactating patients. 3. Patients with acute allergic conditions or history of severe allergic reactions. 4. Patients with acute decompensated chronic lung disease or that may interfere with the monitoring of the underlying disease. 5. Patients with previous history of demyelinating inflammatory or central nervous system disease (CNS) or peripheral (PNS). 6. Patients suffering from uncontrolled intercurrent illness including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, diabetes mellitus and psychiatric diseases involving the incompetence of the subject. 7. Patients with brain metastases. 8. Patients who are receiving other investigational product. 9. Patients with known hypersensitivity to any component of the formulation. 10. Patients with known HIV positive serology, hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerable Dose (dose including 6 subjects). Measurement time: at the end of Phase I. This dose will be used in Phase II (expansion to 3 cohorts per tumor type). Serious adverse events with a demonstrated causal relationship (definite, very probable, or probable) to product administration. Measurement time: every 4 hours or 1 hour as required during product administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (CR/PR). Measurement time: At enrollment, 4 weeks after the last dose of the second cycle, and at months 6, 9, and 12. 2. Overall survival (OS) (Time from patient enrollment to death, regardless of cause, or to the date of last reported death). Measurement time: month 12. 3. Progression-free survival (PFS) (Time from the start of treatment to the date of considered disease progression or death from any cause). Measurement time: month 12. 4. Duration of response (Time from the date the patient achieves a response with study treatment (CR/PR) to objective disease progression or death). Measurement time: up to month 12 in patients who achieve an objective response (CR/PR) with treatment. Immunological Evaluation 1. Expansion of effector T cell populations. Measurement time: baseline, 24 hours after the completion of cycles 1 and 2. 2. Natural killer (NK) cells. Measurement time: baseline, 24 hours after the completion of cycles 1 and 2. 3. Regulatory T cells (Tregs). Measurement time: baseline, 24 hours after the completion of cycles 1 and 2. 4. Memory subpopulations. Measurement time: baseline, 24 hours after the completion of cycles 1 and 2. 5. Activation parameters. Measurement time: baseline, 24 hours after the completion of cycles 1 and 2. Pharmacokinetic parameters. The following will be performed in phase II: 1. Bioavailability-F (estimated value using the Monolix system, SAEM algorithm combined with Monte Carlo coding). Measurement time: After the first dose of cycle 1 and at the last dose of cycles 1 and 2, using a sparse data block design with 4 patients per sample collection design, where each patient will have 14 draws. 2. Volume of distribution (V) (estimated using the Monolix system, SAEM algorithm combined with Monte Carlo coding). Measurement time: After the first dose of cycle 1 and at the last dose of cycles 1 and 2, using a sparse data block design with 4 patients per sample collection design, where each patient will have 1 | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed