prostate and colon cancer
Conditions
Interventions
All patients included in the study will be treated with the HER1 vaccine.
Dose: Initially 2 dose levels (400µg and 800µg) will be opened in each stratum (prostate and colon). In the event of closure o
ErbB Receptors
Vaccines
Injections, Intramuscular
HER1, therapeutic vaccine
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Compliance with one of the two diagnostic criteria defined for each disease (CPRC, CCM). 2. Patient who gives their informed consent to participate in writing. 3. Age over 18 years. 3. General condition according to ECOG = 2. 4. Life expectancy of at least 6 months. 5. Organ and bone marrow function defined by the following parameters: - Hemoglobin (Hb) = 9 g/dl, - Total leukocyte count = 3 x 109/L, - Platelet count (PC) = 100 x 109/L , - Total bilirubin and/or Alkaline Phosphatase = 2.5 times the institutional upper normal limit.
Exclusion criteria
Exclusion criteria: 1. Patients of childbearing age who are not using an adequate method of contraception (intrauterine devices, hormonal contraceptives, barrier methods or surgical sterilization) prior to their inclusion in the study. 2. Pregnant or lactating. 3. Known positive serology for HIV, hepatitis B or C. 4. Decompensated allergic states or history of severe allergic reactions. 5. Acute or chronic decompensated lung diseases. 6. Previous history of demyelinating or inflammatory diseases of the central (CNS) or peripheral (PNS) nervous system. 7. Uncontrolled intercurrent illnesses including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, Diabetes Mellitus and/or psychiatric illness involving the incompetence of the subject. 8. Brain metastasis. 9. Known hypersensitivity to any component of the formulation. 10. Patients who are receiving another investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with serious adverse events with a causal relationship (according to CTCAE criteria and causality criteria: SAE with very probable, probable or possible causation). Measurement time: at all times of administration of the research product. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with neutralizing antibody levels. will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Recognition of the human vulvar tumor line A431. will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Response of IFN ?-producing T cells. It will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Frequency of myeloid suppressor cells (MDSC). will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Frequency and absolute number of T cells (CD4; CD8; Tregs and NK) (flow cytometry). will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Measurement of EGF in serum. will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Inhibition of the ligand (EGF)-HER1 receptor interaction by binding the antibodies generated with the HER1 vaccine in human tumor lines (flow cytometry). will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 Inhibition of HER1 phosphorylation. will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Effect of treatment on the expression of PDL1 and MHC-I. will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Induction of markers of apoptosis such as phosphatidyl serine and DNA fragmentation. will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Dissemination of the antigenic response of the antibodies induced by the treatment (Wester blot, ELISA, Protoarray). will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Cytokines secreted by T cells (ELISA). will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Evaluate the prognostic value of systemic inflammatory indices (NLR, PLR, MRL). The ratio between neutrophils, lymphocytes, platelets and monocytes will be measured, from a complete blood count with differential and a platelet count. It will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Expression of PD1L in the tumor sample (IHC). will be measured on days 0, 56, 84, 112, 140, 196, 252, 336 - Serum levels of proinflammatory cytokines: IL6, IL8 (EL | — |
Countries
Cuba
Contacts
Public ContactLisania Reyes Espinosa
Center of Molecular Immunology (CIM)
Outcome results
None listed