Combination therapy with anti-GD2 antibody immunotherapy (dinutuximab beta) in combination with chemotherapy for refractory neuroblastoma

Phase 1

• Conditions: Recurrent or progression of neuroblastoma or neuroblastoma refractory to first-line treatment; MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10066595Term: Neuroblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10029261Term: Neuroblastoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003832-96-PL
• Lead Sponsor: Jagiellonian University Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).
2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.
3. Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria).
4. Life expectancy =6 months.
5. Obtaining the informed written consent of the patient and / or statutory representative for the treatment.
6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding.
7. Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with toxicities of =3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
2. Patients with neurological toxicities of =2 CTCAE WHO grade.
3. Active life-threatening infection until stabilization of the patient's condition.
4. Pregnancy and / or lactation.
5. Sexually active patients who refuse to use an effective method of contraception.
6. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study.
7. Radiotherapy within 3 weeks prior to the start of the study.
8. Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL).
9. Lack of informed written consent to treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified