Racotumomab vaccine- Lung Cancer- Adults-predictors of response - Exploratory

Phase 1

• Conditions: Advanced non small cell lung cancer; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Carcinoma, Bronchogenic; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Diseases

• Registration Number: RPCEC00000279
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1-Patients who meet the diagnostic criteria.
2-Patients older than or equal to 18 years old.
3-Patients who have signed the informed consent for the investigation.
4-Patients with clinical status according to ECOG from 0 to 2.
5-Patients who have received first-line treatment and reached at least stable disease in response.
6-Patients in which the time between the end of the onco-specific treatment and the inclusion in the study is 4 to 6 weeks.
7-Patients with life expectancy of six months or more.
8-Patients with normal hepatic, renal and hematological functions defined by:
• Hemoglobin greater or equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion)
• Total Leukocyte Count greater or equal to 3.0 x 109 / L
• Absolute Neutrophil Count greater or equal to 1.5 x 109 / L
• Platelet Count greater or equal to 100 x 109 / L
• Bilirubin up to the normal upper limit.
• TGP and TGO: greater or equal to 1.5 times the upper limit for the normal value of the institution, or <5 times the upper limit for the normal value of the institution, if the existence of liver metastasis is known.
• Alkaline phosphatase greater or equal to 2.5 times the normal upper limit.
• Creatinine: Within normal limits for each institution or creatinine clearance> 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.

Exclusion Criteria

1-Patients who have previously received treatment with the anti-idiotypic vaccine Racotumomab.
2- Patients with acute, chronic, or inflammatory decompensated infectious diseases.
3- Patients of childbearing age who do not accept adequate contraceptive methods (intrauterine devices, barrier or tubal ligation methods, hormonal methods).
4- Pregnant or lactating patients.
5- Patients with acute allergic states or history of severe allergic reactions.
6- Patients who are receiving any other product under investigation.
7- Patients with brain metastasis.
8- Patient with other malignant diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Immunocompetence of patients (Frequency and phenotype of B lymphocytes, T and NK cells). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met.<br><br>-Immune response (Title and functionality of antibodies induced by the vaccine). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met.<br><br>-Inhibition of tumor angiogenesis (Concentration of biomarkers related to angiogenesis and tumor inflammation: IL 8, VEGF, FGF, EGF, IL 6) Measurement time: At baseline, at the end of the induction stage ( day 84) and then every three months until the 15 doses<br><br>-Overall Survival: (Time from recruitment until to death, from any cause). Measurement time: 24 months<br><br><br><br>

Secondary Outcome Measures

Name	Time	Method
aboratory tests (numerical values of the Hemogram with differential, GPT, GOT, GGT, Alkaline Phosphatase, LDH, Creatinine, Glycemia). Measurement time: At baseline and, very three months until 24 months.