Status:
UNKNOWN
DNA Vaccination Against Neuroblastoma
Lead Sponsor:
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Conditions:
Relapsed Neuroblastoma
Eligibility:
All Genders
1-20 years
Phase:
EARLY_PHASE1
Brief Summary
This is pilot open-label study to evaluate the safety and immunogenicity of a DNA vaccine strategy in relapsed neuroblastoma patients following chemotherapy and HSC transplantation. The combined form ...
Detailed Description
DNA vaccine construction includes chimeric fusion of neuroblastoma-associated antigen and potato virus X coat protein (PVXCP) as an immune enhancer. In each course vaccine for one antigen is applies. ...
Eligibility Criteria
Inclusion
- The diagnosis of neuroblastoma recurrence with morphological / cytological confirmation;
- The presence of tumor tissue for biopsy;
- The absence of progression or a large tumor mass (bulky disease);
- The physical status on the scale of ECOG 0 - 2.
- Life expectancy of at least 12 months
- Indicators of cellular immunity of the blood: lymphocytes - at least 1 \* 10\^9;
- Availability of written informed consent of the patient and his parents (legal representatives) to participate in this protocol.
- Compliance of parents (legal representatives) and the patient himself with participation in the study protocol.
Exclusion
- A. Based on the anamnesis:
- The presence of any primary immunodeficiency;
- The presence of a primary multiple malignant tumor;
- The presence of autoimmune diseases in history (except thyroiditis);
- Polyalgia;
- Severe diseases, including those with severe symptoms, untreated inflammatory and infectious processes, due to which the patient cannot receive treatment in accordance with the study protocol.
- Socioeconomic or geographical circumstances that cannot guarantee proper compliance with the requirements of the protocol for treatment and further observation.
- B. based on survey data:
- The absence of expression in the tumor tissue of two or more antigens used in the protocol;
- The level of peripheral blood leukocytes \<1.5 × 10\^9 /L, platelet \<50.0 × 10\^9 /L, Hemoglobin less than 80 g / L;
- Positive tests for human immunodeficiency virus (HIV), hepatitis B or C.
- Severe impaired liver function - the levels of AST / SGOT or ALT / SGPT exceed the upper limit of normal 5 times or more.
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04049864
Start Date
January 9 2019
End Date
December 31 2023
Last Update
March 2 2022
Active Locations (1)
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1
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus, 223053