DNA Vaccination Against Neuroblastoma

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 of the vaccine includes an intramuscular injection of the DNA-polyethylenimine conjugate and oral administration using the attenuated Salmonella enterica as DNA vaccine carriers.

Objectives of the study:

1. To assess safety and document local and systemic toxicity to combined DNA vaccine

2. To determine immunogenicity of the vaccine

3. To evaluate clinical response to vaccination. Control of minimal residual disease in bone marrow and duration of remission.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
• Treatments: Lenalidomide; Vaccines

Criteria

Inclusion Criteria:

1. The diagnosis of neuroblastoma recurrence with morphological / cytological confirmation;

2. The presence of tumor tissue for biopsy;

3. The absence of progression or a large tumor mass (bulky disease);

4. The physical status on the scale of ECOG 0 - 2.

5. Life expectancy of at least 12 months

6. Indicators of cellular immunity of the blood: lymphocytes - at least 1 * 10^9;

7. Availability of written informed consent of the patient and his parents (legal representatives) to participate in this protocol.

8. Compliance of parents (legal representatives) and the patient himself with participation in the study protocol.

Exclusion Criteria:

A. Based on the anamnesis:

1. The presence of any primary immunodeficiency;

2. The presence of a primary multiple malignant tumor;

3. The presence of autoimmune diseases in history (except thyroiditis);

4. Polyalgia;

5. 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.

6. 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:

1. The absence of expression in the tumor tissue of two or more antigens used in the protocol;

2. The level of peripheral blood leukocytes <1.5 × 10^9 /L, platelet <50.0 × 10^9 /L, Hemoglobin less than 80 g / L;

3. Positive tests for human immunodeficiency virus (HIV), hepatitis B or C.

4. Severe impaired liver function - the levels of AST / SGOT or ALT / SGPT exceed the upper limit of normal 5 times or more.