Castration resistant prostate cancer
Conditions
Interventions
Group 1 (Experimental). CIMAvax EGF vaccine + Second Line Standard Hormone Therapy
Pre-treatment:
Ciclophosphamide: Day 1 (200 mg/m2) One dose. 72 hours before start CIMAvax-EGF treatment.
CIMAvax-E
according to medical researcher criteria, until patient refusal to continue treatment or any withdrawal criteria appear.
Second Line Standard Hormone Therapy:
First Generation of Androgen Receptor Inh
Androgen Antagonists
Cyclophosphamide
Prednisone
Placebos
Tablets
Injections, Intramuscular
Administration, Oral
Immunization
Single Dose
Docetaxel
Bicalutamida
CIMAvax EGF vaccine
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Male
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Patients who have signed informed consent. 2. Patients who meet the diagnostic criterion of metastatic castration-resistant prostate adenocarcinoma (patient who after receiving surgical or biochemical castration (Testosterone < 50 ng/DL) progresses to a M1 stage corresponding to the IVb phase Of the disease according to the classification proposed by the AJCC in its eighth edition of the 2017 (any T, any N, M1, any grade group, any PSA). 3. Asymptomatic or minimally symptomatic patients. (Low pain levels measured by the Brief pain investigational Short Form Scale (BPI-SF) between 0-1 (asymptomatic) and 2-3 (minimally symptomatic) alleviated with acetaminophen or other non-steroidal anti-inflammatory drugs (CUA, 2015). 4. Patients with imaging study and clinical documentation to corroborate the existence of metastatic lesions prior to the onset of treatment for their metastatic disease, according to RECIST criteria (version 1.1). 5. Patients aged between 18 and 79 years. 6. Patients with life expectancy of 6 months or more. 7. Patients with functional status according to ECOG = 2. 8. Patients with organ and bone marrow functioning defined by the following parameters: Hemoglobin =90 g/L (patients with lower Hb levels should be transfused prior to inclusion), Total leukocyte Count = to 3.0 x 109/L, neutrophil count = 1.5 x 109/L, Platelet count=100 x 109/L, Bilirrubin: Within normal limits for each institution, Glycemia within normal limits for each institution, ALP: Up to 2.5 times the normal upper limit for each institution, GOT/GPT: up to 2.5 times the normal upper limit for each institution, Creatinine: Within normal limits for each institution.
Exclusion criteria
Exclusion criteria: 1. Patients with cerebral metastases, history of primary CNS tumor, uncontrolled convulsions with standard therapy or history of brain vascular accident. 2. Patients with bone pain requiring treatment with opioids. 3. Patients with previous history of demyelinating or inflammatory diseases of the CNS or peripheral. 4. Patients with previous malignant diseases, except skin cancer (non-melanoma), properly treated. 5. Patients with acute allergic states, history of severe allergic reactions or autoimmune diseases. 6. Patients who are receiving another product in research. 7. Patients with a history of allergy attributed to compounds of chemical or biological composition similar to the product under study and/or the proposed Oncoespecífico treatment. 8. Patients carrying uncontrolled intercurrent illnesses, including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illnesses that may Limit adherence to test requirements. 9. Patients with symptoms at the time of diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (Time from randomization until death from any cause). Measurement time: monthly for 3 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression Free Survival-PFS (Time from randomization to progression or death from any cause). Time to measurement: every 3 months for 3 years. 2. Time to progression-TTP (Time from randomization until objective tumor progression). Time to measurement: every 3 months for 3 years. 3. Time to appears symptoms (Time from the start of treatment until the date in which any of the following symptoms appear: Pain, worsening of quality of life (according to scales defined in the protocol) and, development of urinary or digestive symptoms related to the underlying disease indicative of commitment of the urinary or digestive tracts respectively). Time to measurement: every 3 months for 3 years. 4. Objective response (Complete response, Partial Response, Stable Disease, Progressive disease). Time to measure: every 3 months for 3 years. 5. Immunological Response (titer of anti-egf antibodies). Time to measurement: every 2 weeks during the 4 induction doses; monthly for 3 years. 6. Drug requirements (Analgesics, Opioids, Bisphosphonates). Time to measurement: at baseline, monthly for 3 years. 7. Immunogenicity (Good antibody response, Super good antibody response, Poor antibody response). Every 2 weeks during the 4 induction doses; monthly for 3 years. 8. IgG Subclass: (Type of IgG). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years. 9. Immunodominance of the response against EGF (Cellular subpopulation phenotype in peripheral blood). Time to measurement: at baseline, every 3 months for 3 years. 10. Plasmatic EGF concentration (EGF concentration). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years. 11. Urine EGF concentration. (EGF concentration). Time to measurement: Every 2 weeks during the 4 induction doses; monthly for 3 years. 12. Quality of life (EORTC QLQ-C30 and EORTC QLQ-PR25). Time to measurement: at baseline, every 3 months for 3 years. 13. Adverse Events (AE). (Measurable by: -Occurrence | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales
Center of Molecular Immunology
Outcome results
None listed