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High Risk Neuroblastoma clinical trials

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NCT ID: NCT06335745 Not yet recruiting - Neuroblastoma Clinical Trials

PediCARE Health Equity Intervention in High-Risk Neuroblastoma

Start date: September 2024
Phase: N/A
Study type: Interventional

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. The names of the intervention groups in this research study are: - Usual supportive care - PediCARE + usual supportive care

NCT ID: NCT06182410 Not yet recruiting - Neuroblastoma Clinical Trials

Defibrotide Prophylaxis of Transplant Associated-Thrombotic Microangiopathy for Neuroblastoma

Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well defibrotide works in preventing transplant-associated thrombotic microangiopathy (TA-TMA) in patients with high-risk neuroblastoma undergoing tandem transplants (hematopoietic stem cell transplant [HSCT]). TMA is a potential life-threatening complication of stem cell transplant. TMA is a possible side effect of the chemotherapy (conditioning regimen) patients receive to help treat high-risk neuroblastoma, because these medicines can sometimes damage the blood vessel walls in the body. This damage leads to formation of tiny blood clots in organs, especially the kidney. This then causes organ damage and leads to problems with how they function. This study may help researchers learn how defibrotide may help prevent TMA before it starts, or help treat it once it starts among patients with high-risk neuroblastoma undergoing tandem transplants.

NCT ID: NCT06057948 Recruiting - Neuroblastoma Clinical Trials

A Study of a Vaccine in Combination With Beta-glucan in People With Neuroblastoma

Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.

NCT ID: NCT05650749 Recruiting - Clinical trials for Refractory Neuroblastoma

GPC2 CAR T Cells for Relapsed or Refractory Neuroblastoma

GPC2
Start date: May 23, 2023
Phase: Phase 1
Study type: Interventional

This is a first in human dose escalation trial to determine the safety of administering GPC2 CAR T cells in patients with advanced neuroblastoma.

NCT ID: NCT05489887 Recruiting - Clinical trials for High-risk Neuroblastoma

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

Start date: September 14, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy. Naxitamab will be added to all 5 Induction cycles. Subjects with an ALK mutation or amplification will have ceritinib added to their treatment regimen as soon as results are available. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

NCT ID: NCT05373901 Completed - Clinical trials for High-risk Neuroblastoma

Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta as Maintenance Therapy in Chinese Patients With High-risk Neuroblastoma

Start date: June 7, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study is for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese patients with high-risk neuroblastoma

NCT ID: NCT05272371 Recruiting - Clinical trials for High-Risk Neuroblastoma

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

ChIm-NB-PL
Start date: December 1, 2021
Phase: Phase 1
Study type: Interventional

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 patient's 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.

NCT ID: NCT04751383 Active, not recruiting - Clinical trials for Recurrent Neuroblastoma

Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma

Start date: August 31, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial is to find out the best dose, possible benefits and/or side effects of magrolimab in combination with dinutuximab in treating patients with neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory) or relapsed osteosarcoma. Magrolimab and dinutuximab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. The combination of magrolimab and dinutuximab may shrink or stabilize relapsed or refractory neuroblastoma or relapsed osteosarcoma. In addition, this trial may help researchers find out if it is safe to give magrolimab and dinutuximab after surgery to remove tumors from the lungs.

NCT ID: NCT04501757 No longer available - Clinical trials for High-Risk Neuroblastoma

Naxitamab and GM-CSF in People With Neuroblastoma

Start date: n/a
Phase:
Study type: Expanded Access

This is an Expanded Access Program (EAP) that will give the participants access to the drug naxitamab before it is approved by the FDA. Naxitamab will be combined with granulocyte-macrophage colony stimulating factor (GM-CSF). Participants in this study will have high-risk neuroblastoma that either went away completely after treatment (complete remission) or has come back (relapsed/refractory). Researchers think the combination of naxitamab and GM-CSF will be effective because naxitamab and GM-CSF strengthen the immune system's response to cancer cells in different ways. Naxitamab is an antibody, like the proteins made by the immune system to protect the body from harm. Naxitamab helps the cells of the immune system to find and attack cancer cells. GM-CSF is a protein that strengthens the immune system by increasing the number of immune cells called granulocytes. Granulocytes are white blood cells that fight off cancer cells. The combination of naxitamab and GM-CSF is a type of immunotherapy.

NCT ID: NCT04221035 Recruiting - Clinical trials for High-Risk Neuroblastoma

High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

HR-NBL2
Start date: November 5, 2019
Phase: Phase 3
Study type: Interventional

This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk neuroblastoma.