Racotumomab-alum cancer vaccine for solid tumors in pediatric patients

Phase 1

• Conditions: euroblastoma, Nephroblastoma, Ewing's Sarcoma; pediatric solid tumors; Neuroblastoma; Sarcoma, Ewing; Wilms Tumor; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial

• Registration Number: RPCEC00000206
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients older than 1 year of age and under 19 years.
2. Patients who meet the diagnostic criteria.
3. Patients in which the period between the end of the last oncoespecifica therapy and study inclusion is not less than 30 nor more than 60 days.
4. Voluntary patient and / or family or guardian to participate in the study by signing the informed consent model.
5. Patients who are using contraceptive methods if sexually active
6. Patients with histologically confirmed tumors that express NeuGc-GM3 in tumor tissue.
7. General health as Karnofsky index (KPS) = 50% (over 16 years), Lansky = 50% (for those under 16 years)
8. Patients with a life expectancy = 3 months
9. Laboratory parameters within normal limits defined as:
- Hematology: Hemoglobin = 100 g / L, absolute neutrophil count = 1500 cells / L, platelets = 100x109 / L
- Liver function: Within normal limits defined by TGP, TGO = 2.5 above the reference value
- Renal function: Serum creatinine = 1.5 above the reference value.

¿No es correcto?

1. Patients older than 1 year of age and under 19 years.
2. Patients who meet the diagnostic criteria.
3. Patients in which the period between the end of the last oncoespecifica therapy and study inclusion is not less than 30 nor more than 60 days.
4. Voluntary patient and / or family or guardian to participate in the study by signing the informed consent model.
5. Patients who are using contraceptive methods if sexually active
6. Patients with histologically confirmed tumors that express NeuGc-GM3 in tumor tissue.
7. General health as Karnofsky index (KPS) = 50% (over 16 years), Lansky = 50% (for those under 16 years). (Annex 2)
8. Patients with a life expectancy = 3 months
9. Laboratory parameters within normal limits defined as:
- Hematology: Hemoglobin = 100 g / L, absolute neutrophil count = 1500
cells / L, platelets = 100x109 / L
- Liver function: Within normal limits defined by TGP, TGO = 2.5
above the reference value
- Renal function: Serum creatinine = 1.5 above the reference value

Exclusion Criteria

1. Patients participating in another clinical trial.
2. Patients who are pregnant or nursing
3. Patients with a history of encephalopathy, seizures or severe allergies.
4. Patients who at the time of inclusion present associated chronic diseases in decompensation stage.
5. Patients who present a history of hypersensitivity to the product or any component
6. Patients with febrile states, and / or severe septic processes.
7. Patients with immunosuppressive disease or HIV positive.
8. Patients who have been treated with specific immunotherapy in the 6 months prior to inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events related to vaccine (AE with causality relationship: definitive, very probable, probable, and possible). Measuring time: in every administration of the vaccine

Secondary Outcome Measures

Name	Time	Method
Antibody titers against NGcGM3 (The inverse of the highest serum dilution giving optical density = 0.25 and twice the value of the pre-immune serum). Measuring time: at baseline, 3, 6, 9 and 12 months of treatment.<br>Ability to lyse ganglioside expressing cells (Percentage of dead cells =20 %, after subtracting the pre-immune to hyper-immune percent). Measuring time: at baseline, 3, 6, 9 and 12 months of treatment<br>