Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05272371
Status:
RECRUITING
Last Update Posted:
2022-03-09
First Post:
2022-03-01
Brief Title:
Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
Official Title:
Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
Status:
RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ChIm-NB-PL
Brief Summary:
Safety evaluation and initial efficacy evaluation will be conducted in a group of patients as a non-commercial open-label clinical trial of dinutuximab beta Qarziba phase IIa
The investigational medicinal product will be dinutuximab beta anti-GD2 antibodies against GD2 disialoganglioside on NBL cells at a dose of 10 mg m2 day by continuous infusion for 5 days in combination with irinotecan temozolomide topotecan temozolomide or N5 N6 chemotherapy GPOH protocol
The study group will be patients with recurrent progression of NBL or disease resistant to first-line treatment for whom there are currently no standards of management and the treatment methods used so far do not give a chance to achieve a permanent remission of the disease After diagnosis of relapse progression or resistance to treatment it is permissible to administer 2 cycles of standard chemotherapy prior to enrollment in the study
The study plans to recruit 20 patients who will receive 5-7 cycles of DB with chemotherapy The choice of an appropriate chemotherapy regimen will depend on the patients prior treatment and tolerance
The safety assessment will be conducted based on the registration of the types and frequency of adverse reactions identified on the basis of the registration of clinical parameters symptoms and or diseases reported by the patient or identified during the intervention and or follow-up visits abnormal laboratory and or imaging test results
The initial assessment of the effectiveness will consist in comparing the percentage of objective responses obtained and the annual EFS and PFS imaging tests including scintigraphy bone marrow examination and tumor markers The study also included an exploratory evaluation of the usefulness of immunological genetic and other studies
The investigational medicinal product will be dinutuximab beta anti-GD2 antibodies against GD2 disialoganglioside on NBL cells at a dose of 10 mg m2 day by continuous infusion for 5 days in combination with irinotecan temozolomide topotecan temozolomide or N5 N6 chemotherapy GPOH protocol
The study group will be patients with recurrent progression of NBL or disease resistant to first-line treatment for whom there are currently no standards of management and the treatment methods used so far do not give a chance to achieve a permanent remission of the disease After diagnosis of relapse progression or resistance to treatment it is permissible to administer 2 cycles of standard chemotherapy prior to enrollment in the study
The study plans to recruit 20 patients who will receive 5-7 cycles of DB with chemotherapy The choice of an appropriate chemotherapy regimen will depend on the patients prior treatment and tolerance
The safety assessment will be conducted based on the registration of the types and frequency of adverse reactions identified on the basis of the registration of clinical parameters symptoms and or diseases reported by the patient or identified during the intervention and or follow-up visits abnormal laboratory and or imaging test results
The initial assessment of the effectiveness will consist in comparing the percentage of objective responses obtained and the annual EFS and PFS imaging tests including scintigraphy bone marrow examination and tumor markers The study also included an exploratory evaluation of the usefulness of immunological genetic and other studies
Detailed Description:
Neuroblastoma NBL accounts for 8-10 of all childhood malignancies It is the most common solid tumor outside the central nervous system in people 18 years of age It occurs in 6-11 1 million children annually In Poland NBL is diagnosed annually in 60-70 patients in 13 high-risk disease HR In 90 of children NBL is diagnosed before the age of 5 The diagnosis is made on the basis of the histopathological assessment of the tumor tissue or the presence of NBL cells in the bone marrow together with elevated levels of catecholamines or their metabolites in the urine The prognostic factors include the patients age at diagnosis stage of disease tumor histopathology DNA ploidy MYCN gene status chromosomal changes and initial response to therapy Due to the different course of the disease the therapeutic decision is made after determining the risk group based on international criteria International Neuroblastoma Risk Group Stage System INRGSS and International Neuroblastoma Staging System INSS In the lowest-risk group management is limited to observation or surgery and in the intermediate-risk group only standard low- and intermediate-intensity chemotherapy or combined with radiation therapy and surgery is performed In contrast HR-NBL uses intensive combination therapy including standard induction chemotherapy surgery high-dose chemotherapy HD-CHT and autologous hematopoietic stem cell transplantation auto-HSCT radiotherapy and maintenance therapy with 13-cis retinoic acid and targeted immunotherapy with anti-GD2 antibodies Treatment outcomes in NBL vary from spontaneous tumor regression in some infants to an OS rate of 50 despite intensive combination therapy in the HR-NBL group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None