Clinical trials: High-Risk Neuroblastoma
Ependymoma, Ewing Sarcoma
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children…
- Conditions
- Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma
- Trial name
- PIVOT IO 020 (NCT04730349)
- Testing
- Nivolumab, NKTR-214
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 15 people
- Sponsor
- Bristol-Myers Squibb
Neuroblastoma, Neuroectodermal Tumors
A Study of Therapeutic Iobenguane (131-I) and Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects
The purpose of this study is to evaluate the efficacy and safety of 131I-MIBG in combination with Vorinostat in patients with Recurrent or Progressive neuroblastoma
- Conditions
- Neuroblastoma, Neuroectodermal Tumors, Neoplasms
- Trial name
- OPTIMUM (NCT03561259)
- Testing
- 131I-MIBG, 131-MIBG + Vorinostat
- Where
- 21 sites in United States
- Volunteers
- 60 people
- Sponsor
- Jubilant DraxImage Inc.
Neuroblastoma, Relapsed Neuroblastoma
67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
- Conditions
- Neuroblastoma, Relapsed Neuroblastoma, Refractory Neuroblastoma
- Trial name
- NCT04023331
- Testing
- 67Cu-SARTATE, 64Cu-SARTATE
- Where
- 8 sites in United States
- Volunteers
- 21 people
- Sponsor
- Clarity Pharmaceuticals Ltd
Neuroblastoma
Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and…
- Trial name
- NCT03363373
- Testing
- GM-CSF + Naxitamab
- Where
- 20 sites in United States, Canada and 7 more
- Volunteers
- 122 people
- Sponsor
- Y-mAbs Therapeutics
SCLC, Malignant Melanoma
GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2
Patients with Small Cell Lung Cancer, High Risk Neuroblastoma, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA…
- Conditions
- SCLC, Malignant Melanoma, Sarcoma, High Risk Neuroblastoma
- Trial name
- NCT05130255
- Testing
- GD2-SADA (0.3 mg/kg) and 177Lu-DOTA (30 mCi), GD2-SADA (3 mg/kg) 177Lu-DOTA (30 mCi), GD2-SADA (0.3 mg/kg) 177Lu-DOTA (200 mCi)
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Y-mAbs Therapeutics
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Neuroblastoma Recurrent
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
An International, Single-Arm, Multicenter Phase 2 Trial.
- Trial name
- NCT04560166
- Testing
- Naxitamab and GM-CSF in combination with irinotecan and temozolomide
- Where
- 3 sites in Hong Kong, South Korea
- Volunteers
- 2 people
- Sponsor
- Y-mAbs Therapeutics
Osteosarcoma, Medulloblastoma
A Study of Pemetrexed in Children With Recurrent Cancer
To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma…
- Conditions
- Osteosarcoma, Medulloblastoma, Sarcoma, Ewing's, Neuroblastoma (Measurable Disease)
- Trial name
- NCT00520936
- Testing
- pemetrexed
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Eli Lilly and Company
Neuroblastoma
N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumor cells and not harm normal cells.
- Trial name
- NCT00659984
- Testing
- UltratraceTM Iobenguane I 131 Imaging, UltratraceTM Iobenguane I 131 Therapy
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Relapsed Neuroblastoma, Refractory Neuroblastoma
Dual-Target GD2/B7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma
This illustrative Phase 1/Phase 2 study tests allogeneic dual-target GD2/B7-H3 (CD276) CAR-NK cells in children and young adults with relapsed or refractory neuroblastoma.
- Conditions
- Relapsed Neuroblastoma, Refractory Neuroblastoma, High-Risk Neuroblastoma, Ganglioneuroblastoma
- Trial name
- DUAL-NK-NB (NCT07502287)
- Testing
- EB-DTNB-NK, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Beijing Biotech
Diffuse Astrocytoma, Anaplastic Astrocytoma
Pediatric Long-Term Follow-up and Rollover Study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
- Trial name
- NCT03975829
- Testing
- dabrafenib, trametinib
- Where
- 54 sites in United States, Argentina and 17 more
- Volunteers
- 163 people
- Sponsor
- Novartis Pharmaceuticals
High-risk Neuroblastoma
Evaluation of the Safety and Pharmacokinetics of Dinutuximab Beta As Maintenance Therapy in Chinese Participants With High-Risk Neuroblastoma
This was an open-label, multi-center, single-arm, Phase 1 study. The purpose of this study was for evaluating the safety and pharmacokinetics of dinutuximab beta as maintenance therapy in Chinese participants with high-risk…
- Trial name
- NCT05373901
- Testing
- Dinutuximab Beta, 13-cis-Retinoic Acid
- Where
- 3 sites in China
- Volunteers
- 8 people
- Sponsor
- BeiGene
Relapsed Solid Tumor, Refractory Solid Tumor
A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma
The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did…
- Trial name
- NCT04238819
- Testing
- Abemaciclib, Irinotecan, Temozolomide
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 47 people
- Sponsor
- Eli Lilly and Company
Neuroblastoma
Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.
This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission.
- Trial name
- NCT04909515
- Testing
- Naxitamab, GM-CSF, Isotretinoin
- Where
- 9 sites in Hong Kong, Russia and 2 more
- Sponsor
- Y-mAbs Therapeutics
Neuroblastoma
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.
- Trial name
- NCT02693171
- Testing
- Dinutuximab
- Where
- 18 sites in United States
- Volunteers
- 13 people
- Sponsor
- United Therapeutics
Primary Refractory Neuroblastoma
A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma Patients
This is a multicenter, randomized, controlled, open-label study. Patients meeting inclusion/exclusion criteria will be randomized (1:1) to receive two cycles of MAb-3F8 plus GM-CSF or RA plus GM-CSF.
- Trial name
- NCT00969722
- Testing
- MAb-3F8, Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), 13-cis-Retinoic Acid
- Where
- 15 sites in United States
- Volunteers
- 1 people
- Sponsor
- United Therapeutics
Neuroblastoma, Recurrent, Refractory, Neuroblastoma (NB)
Safety and Efficacy of Systemic Allogenic NK Cells in R/R Neuroblastoma
The goal of this clinical trial is to assess safety and efficacy of systemic injection of allogenic NK cells in patients with refractory/recurrent high-risk neuroblastoma.
- Conditions
- Neuroblastoma, Recurrent, Refractory, Neuroblastoma (NB), Neuroblastoma in Children
- Trial name
- NCT06674265
- Testing
- Allogenic NK cells infusion
- Where
- Iran
- Volunteers
- 10 people
- Sponsor
- Marzieh Ebrahimi
Neuroblastoma
Racotumomab in Patients With High-risk Neuroblastoma
This clinical trial will be carried out in children diagnosed with high-risk neuroblastoma that have achieved a complete or very good partial response after standard therapy.
- Trial name
- NCT02998983
- Testing
- Racotumomab
- Where
- 2 sites in Argentina
- Volunteers
- 39 people
- Sponsor
- Laboratorio Elea Phoenix S.A.
High-Risk Neuroblastoma
A Safety and Efficacy Study of hu14 in High-Risk Neuroblastoma Patients
Neuroblastoma is the most common type of solid cancer found outside the brain in young children. Generally, it affects children younger than 5 years old, with the average age when it is found being just 2 years.
- Trial name
- SHINE (NCT07549321)
- Testing
- hu1418K322A + Temozolomide + Irinotecan
- Where
- 18 sites in United States, Canada and 5 more
- Volunteers
- 144 people
- Sponsor
- Renaissance Pharma Ltd.
Neuroblastoma
Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors
This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors…
- Trial name
- NCT05429502
- Testing
- Topotecan, Temozolomide, Ribociclib
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals