Solid tumors CD 318+, Breast cancer, Colon cancer, Ovarian cancer
Conditions
Interventions
Group A (Experimental): Itolizumab in two stages, Induction (stage I) and Maintenance (stage II). In stage I, the patient will receive a dosage of 100 mg, by endovenous route, every 7 days duringfor 8
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria. 2. Patients who give their informed consent for participation in writing. 3. Patients of either sex aged over 18 years. 4. Patients with general condition = 2 (according to ECOG) 5. Patients with life expectancy of at least 3 months. 6. Patients who do not agree to receive another available cancer treatment option. 7. Patients with organ and bone marrow function defined by the following parameters: Hemoglobin = 10 g/dl,total Leukocyte Count = 3 x 109/L,Platelet count = 100 x 109/L, total bilirubin: within normal limits for the institution, TGP and TGO =2.5 times the institutional upper normal limit, creatinine:within normal limits for the institution.
Exclusion criteria
Exclusion criteria: 1. Patients of childbearing age who are not using an adequate method of contraception prior to inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). In the case of the male sex (vasectomy, use of condoms). 2. Pregnant or lactating patients. 3. Patients with acute allergic states or a history of severe allergic reactions. 4. Patients with acute or chronic decompensated lung diseases that may interfere with the monitoring of the underlying disease. 5. Patients with intercurrent uncontrolled diseases that include, but are not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes mellitus and psychiatric diseases that imply incompetence of the subject. 6. Patients who are receiving another investigational product or have recently finished the use of any monoclonal antibody. 7. Patients with known hypersensitivity to any component of the formulation. 8. Patients with known positive serology for HIV, hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serious adverse event of intensity grade 3/4 that threatens/incapacitates or that produces death (From the total number of patients who will receive treatment, the percentage that developed serious AEs will be calculated, according to the (CTCAE v5) classification). Measurement time: During the treatment until month 12. 2.Objective response rate (Complete Response o Partial Response according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). It will be classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)). Measurement time: Week 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (Time elapsed from randomization until the patient's death will be measured, regardless of the cause or until the date of the latest news by clinical history). Measurement time: 12 months. 2. Immunological evaluation (The expansion of the populations of effector T lymphocytes, natural killer cells (NK) and Treg lymphocytes will be evaluated. In these populations, the memory subpopulations and the activation parameters will also be estimated. The ROC curves will be evaluated to study possible predictive thresholds of OR, SV and PFS. Thresholds will be evaluated as those that maximize the Sensitivity (probability of detecting a positive result if the objective response is positive) and Specificity (probability of detecting a negative result if there is no objective response) of the Area under the ROC curve. If such thresholds are obtained, the immunological variables will be categorized and the positive predictive values (VP+), the negative predictive values (VP-) and the % of classifications will be estimated, correctly evaluated with their respective 95% confidence intervals). Measurement time: Day 0 and weeks 8,11,26,30 and 48. 3. Response duration (Time, in days, elapsed from the date the patient achieves a response with study treatment (CR/PR) to objective disease progression or death). Measurement time: 12 months | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology (CIM)
Outcome results
None listed