Neoplasms

All Conditions

Rare Diseases

Neuroblastoma

Ganglioneuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Dermatologic Agents

All Drugs and Chemicals

Micronutrients

Antirheumatic Agents

Cardiotonic Agents

Anti-Infective Agents

Vitamins

Amino Acids

Tretinoin

Carboplatin

Vitamin A

Retinol palmitate

Antibodies

Antibodies, Monoclonal

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Molgramostim

Sargramostim

Topotecan

Vincristine

Melphalan

Cisplatin

Daunorubicin

Etoposide phosphate

Podophyllotoxin

Immunoglobulins

Thiotepa

Isotretinoin

Mechlorethamine

Nitrogen Mustard Compounds

Dexrazoxane

Razoxane

Dinutuximab

3,6-bis(5-chloro-2-piperidyl)-2,5-piperazinedione

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

Keratolytic Agents

Protective Agents

Retinol

Phenylalanine

Alanine

Autologous Hematopoietic Stem Cell Transplantation

External Beam Radiation Therapy

Sara M Federico

This phase II pilot trial studies the side effects and how well dinutuximab and sargramostim work when combined with chemotherapy in patients with high-risk neuroblastoma. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Sargramostim helps the body produce normal infection-fighting white blood cells. These cells also help the dinutuximab work better. Giving chemotherapy before a stem cell transplant, with drugs such as cisplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, thiotepa, melphalan, etoposide, carboplatin, topotecan, and isotretinoin, helps kill cancer cells that are in the body and helps make room in a patient's bone marrow for new blood-forming cells (stem cells). Giving dinutuximab and sargramostim with combination chemotherapy may work better than combination chemotherapy alone in treating patients with high-risk neuroblastoma.

PRIMARY OBJECTIVE:

I. To assess the feasibility and tolerability of administering ch14.18 (dinutuximab) and sargramostim (GM-CSF) in combination with a multi-agent chemotherapy regimen during cycles 3-5 of the Induction phase for patients with newly-diagnosed high-risk neuroblastoma.

SECONDARY OBJECTIVE:

I. To describe the response rates, event-free survival (EFS) and overall survival (OS) for patients receiving the combination of standard Induction chemotherapy and ch14.18 (dinutuximab) followed by tandem transplant, radiation therapy, and post-consolidation immunotherapy.

EXPLORATORY OBJECTIVES:

I. To describe the clinical relevance of naturally occurring anti-glycan antibodies in patients receiving ch14.18 (dinutuximab).

II. To describe the clinical relevance of natural killer (NK) receptor NKp30 isoforms in patients receiving ch14.18 (dinutuximab).

III. To describe the association between host factors, including human anti-chimeric antibodies (HACA), and response to protocol therapy.

IV. To describe the immune environment (gene expression; immune effector cells, activities and signaling molecules; immune target expression) during and following treatment.

V. To describe the association between levels of circulating GD2, and tumor cell GD2 expression with response to therapy.

OUTLINE:

INDUCTION CYCLES 1-2 (21 days): Patients receive cyclophosphamide intravenously (IV) over 15-30 minutes and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity.

INDUCTION CYCLE 3: Patients receive cisplatin IV over 1 hour on days 1-3, etoposide IV over 2 hours on days 1-3, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim subcutaneously (SC) on day 6 or 7 of a 21-day cycle.

INDUCTION CYCLE 4: Patients receive vincristine IV over 1 minute on day 1, doxorubicin IV over 1-15 minutes on days 1-2, cyclophosphamide IV over 1 hour on days 1-2, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC on day 6 or 7 of a 21-day cycle.

INDUCTION CYCLE 5: Patients receive cisplatin IV over 1 hour on days 1-3, etoposide IV over 2 hours on days 1-3, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC on day 6 or 7 of a 21-day cycle.

Patients may undergo surgery after the fourth or fifth cycle of Induction at the discretion of treating doctor. Patients with stable disease or better tumor response at the end of Induction proceed to Consolidation. Consolidation treatment begins between 4 and 6 weeks from the start date of Induction chemotherapy cycle 5. For patients who have surgical resection delayed until after Induction chemotherapy cycle 5, Consolidation starts within 4 weeks from the date of surgery.

CONSOLIDATION #1: Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour on days -5 to -2. Patients then undergo autologous stem cell transplant (ASCT) on day 0.

CONSOLIDATION #2: Patients receive melphalan IV over 30 minutes on days -7 to -5, etoposide IV over 24 hours on days -7 to -4, and carboplatin IV over 24 hours on days -7 to -4. Patients then undergo ASCT on day 0.

RADIATION THERAPY: Beginning 42-80 days following Consolidation #2, patients receive external beam radiation therapy (EBRT) daily for up to 20 days.

Patients then receive post-Consolidation therapy starting at least 1 week following radiation therapy.

POST-CONSOLIDATION CYCLES 1-5: Patients receive sargramostim SC on days 1-14, dinutuximab IV over 10-20 hours on days 4-7, and isotretinoin orally (PO) twice daily (BID) on days 11-24. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

POST-CONSOLIDATION CYCLE 6: Patients receive isotretinoin PO BID on days 15-28 of a 28-day cycle.

After completion of study treatment, patients are followed up at months 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, and 60.

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

The Incidence of Naturally Occurring Anti-glycan Antibodies was calculated, including placement of a 95% CI on the incidence. In addition, anti-glycan levels prior to the start of Induction therapy and prior to the start of post-Consolidation therapy was compared with Wilcoxon's signed-rank test for paired data.

Assessed by calculating the incidence of NK receptor NKp30 isoforms, including placement of a 95% CI on the incidence.

Explored with Fisher's exact test for categorical and Wilcoxon rank-sum test for continuous host factors. Both the presence/absence and level of naturally occurring anti-glycan antibodies was considered. For the KIR/KIR-L analysis, patients were categorized as either matched or mismatched. Patients were grouped into one of the three genotype subgroups of Fc receptor genotyping for that analysis. The presence/absence of HACA, anti-idiotype, and pretreatment anti-therapeutic antibodies (PATA)/anti-allotype antibody was considered for the HACA analysis.

The incidence of NK receptor NKp30 isoforms was calculated, including placement of a 95% CI on each incidence rate. Summary statistics were generated for serum cytokine (IL6, CXCL9) levels and gene expression of circulating immune function cells.

Assessed by exploring the relationship between response to treatment with \> PR (response vs. non- response) with circulating GD2 levels, and GD2 tumor cell expression following therapy with a Wilcoxon rank-sum test. Changes from baseline were also analyzed.

Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Assessed by estimation of the combined toxic death and unacceptable toxicity rate during Induction cycles 3-5 together with a 95% confidence interval.

Feasibility "failures" were defined as patients that did not receive \>= 75% of the planned dinutuximab doses during Induction cycles 3-5. Assessed by estimation of the feasibility "failure" rate together with a 95% confidence interval.

Per the revised INRC, response is comprised by responses in 3 components: primary tumor, soft tissue and bone metastases, and bone marrow. Primary and metastatic soft tissue sites were assessed using Response Evaluation Criteria in Solid Tumors and MIBG scans or FDG-PET scans if the tumor was MIBG non-avid. Bone marrow was assessed by histology or immunohistochemistry and cytology or immunocytology. Complete response (CR) - All components meet criteria for CR. Partial response (PR) - PR in at least one component and all other components are either CR, minimal disease (in bone marrow), PR (soft tissue or bone) or not involved (NI; no component with progressive disease (PD). Minor response (MR) - PR or CR in at least one component but at least one other component with stable disease; no component with PD. Stable disease (SD) - Stable disease in one component with no better than SD or NI in any other component; no component with PD. Progressive disease (PD) - Any component with PD.

Per the revised INRC, progressive disease is: 1) \> 20% increase in the longest diameter of the primary tumor, taking as reference the smallest sum and ¬\> increase of 5 mm in longest dimension, 2) Any new soft tissue lesion detected by CT/MRI that is MIBG avid or FDG-PET avid, 3) Any new soft tissue lesion seen on CT/MRI that is biopsied and found to be neuroblastoma or ganglioneuroblastoma, 4) Any new bone site that is MIBG avid, 5) Any new bone site that is FDG-PET avid and has CT/MRI findings of tumor or is histologically neuroblastoma or ganglioneuroblastoma 6) A metastatic soft tissue site with \> 20% increase in longest diameter, taking as reference the smallest sum on study, and with \> 5mm in sum of diameters of target soft tissue lesions, 7) A relative MIBG score ¬\> 1.2, 8) Bone marrow without tumor infiltration that becomes \>5% tumor infiltration, 9) Bone marrow with tumor infiltration that increases by \> 2-fold and has \> 20% tumor infiltration on reassessment.

Kaplan-Meier method was used to estimate overall survival (OS). OS was defined as the time from study enrollment to death. 1-year OS is provided.

National Cancer Institute (NCI)

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Patients receive 5 cycles of Induction chemotherapy including cyclophosphamide, topotecan, cisplatin, etoposide, dinutuximab, sargramostim, vincristine, and doxorubicin. Patients may undergo surgery after Cycle 4 or 5 of Induction at the discretion of treating doctor. Patients with stable disease or better tumor response at end of Induction proceed to Consolidation. Consolidation treatment begins between 4-6 weeks from the start date of Induction cycle 5. For patients who have surgical resection delayed until after Induction cycle 5, Consolidation starts within 4 weeks from the date of surgery. Patients then undergo 2 cycles of Consolidation including thiotepa, cyclophosphamide, melphalan, etoposide, and carboplatin, followed by Radiation therapy beginning 42-80 days following Consolidation Cycle #2. Patients then receive 6 cycles of post-Consolidation therapy starting at least 1 week following radiation therapy, including sargramostim, dinutuximab, and isotretinoin.

Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Australia

New Zealand

Region of Enrollment

Results Reporting Coordinator

All eligible patients who received at least one dose of ch14.18 (dinutuximab) during Induction cycles

Percentage of Participants With Unacceptable Toxicity

Percentage of Participants Who Are Feasibility "Failure"

All eligible patients. Institutional assessment of end-induction response has been used.

Response Rate

Event-free Survival

Overall Survival

Incidence of Naturally Occurring Anti-glycan Antibodies

Incidence of Natural Killer (NK) Receptor NKp30 Isoforms

Response of Host Factors, Including Naturally Occurring Anti-glycan Antibodies, KIR/KIR-L Genotyping, Fc Receptor Genotyping, Human Anti-chimeric Antibodies (HACA)

Immune Environment (Gene Expression; Immune Effector Cells, Activities and Signaling Molecules; Immune Target Expression)

Levels of Circulating GD2 and Tumor Cell GD2 Expression

Overall Study

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Recurrence

Osteosarcoma

Disease Attributes

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Immunomodulating Agents

Magrolimab

Antineoplastic Agents, Immunological

Patients receive magrolimab IV and dinutuximab IV on study. Patients also undergo CT, MRI, and blood sample collection on study, as well as bone marrow aspiration and biopsy throughout the trial.

Patients receive magrolimab IV and dinutuximab IV on study. Patients with pulmonary osteosarcoma may undergo surgical resection of tumor after cycle 1. After surgery, these patients continue receiving magrolimab and dinutuximab on study. Patients also undergo CT, MRI, and collection of blood samples on study, as well as bone marrow aspiration and biopsy throughout the trial.

Biospecimen Collection

Bone Marrow Aspiration

Bone Marrow Biopsy

Computed Tomography

Magnetic Resonance Imaging

Resection

Robbie G Majzner

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.

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of Hu5F9-G4 (magrolimab) in combination with dinutuximab in children and young adults with relapsed/refractory (R/R) neuroblastoma (NBL) or relapsed osteosarcoma.

II. Determine the recommended phase 2 dose (RP2D) of Hu5F9-G4 (magrolimab) given in combination with dinutuximab in children and young adults.

III. Determine the safety and feasibility of administering Hu5F9-G4 (magrolimab) in combination with dinutuximab to patients that undergo pulmonary resection of metastatic osteosarcoma within three weeks of surgery.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics (PK) of Hu5F9-G4 (magrolimab) in children and young adults.

II. Evaluate the event free survival (EFS) in two cohorts of patients who are treated at the recommended phase 2 dose (RP2D) (measurable relapsed osteosarcoma and patients with pulmonary relapse undergoing resection) and compare to historical controls.

III. Observe and record anti-tumor activity. IV. Evaluate the overall response rate (ORR) of patients in the NBL cohorts (measurable R/R NBL and evaluable R/R NBL) and osteosarcoma patients (measurable relapsed osteosarcoma) in the expansion cohorts treated at the RP2D.

EXPLORATORY OBJECTIVES:

I. To explore biomarkers of response and resistance including genomic (CD47 expression, Fc receptor \[FcR\] polymorphisms, SIRPa polymorphisms, and KiR phenotype) and immunologic (dinutuximab human anti-chimeric antibody \[HACA\], magrolimab anti-drug antibody \[ADA\], peripheral and bone marrow immune subsets, and circulating cytokines).

II. To explore biomarkers of response in the tumor microenvironment through multiplexed ion beam imaging (MIBI) on resected tissue or archival tissues including comparison of pre- and post- treatment tumor tissues from patients undergoing staged resection of pulmonary osteosarcoma.

OUTLINE: This is a dose de-escalation study of magrolimab with fixed-dose dinutuximab followed by a dose-expansion study. Patients are assigned to 1 of 2 arms.

ARM A: Patients receive magrolimab intravenously (IV) and dinutuximab IV on study. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and blood sample collection on study, as well as bone marrow aspiration and biopsy throughout the trial.

ARM B: Patients receive magrolimab IV and dinutuximab IV on study. Patients with pulmonary osteosarcoma may undergo surgical resection of tumor after cycle 1. After surgery, these patients continue receiving magrolimab and dinutuximab on study. Patients also undergo CT, MRI, and collection of blood samples on study, as well as bone marrow aspiration and biopsy throughout the trial.

After completion of study treatment, patients are followed up at months 2, 4, 6, 9 and 12 and then yearly until year 5, or until disease progression.

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

Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma

Safety data will be analyzed per standard methods and interpreted descriptively. Safety data will be summarized for each disease group separately and for both disease groups combined. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events version 5.0 for type and severity of event. Serious Adverse Events will be summarized for each disease group and for both disease groups combined.

Measured by Response Evaluation Criteria in Solid Tumors version 1.1. Measurable soft tissue disease will be evaluated as per the International Neuroblastoma Response Criteria, and responses will be determined as either complete response (CR), partial response (PR), stable disease or progressive disease. Response rates will be calculated for the measurable neuroblastoma cohort whose best response is a CR or PR.

The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus time. Serum concentrations will be listed and summarized for magrolimab using descriptive statistics by sampling timepoint and cohort. Graphical plots of individual serum concentration versus time and mean concentration versus time by cohort will be generated.

Analgesics

Aldesleukin

Interleukin-2

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Serine

Patients receive sargramostim SC or IV over 2 hours on days 0-13 of courses 1, 3, and 5; monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4; and isotretinoin PO BID on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5. Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4. Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Diagnostic Laboratory Biomarker Analysis

Mehmet F Ozkaynak

This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.

PRIMARY OBJECTIVES:

I. To comprehensively define the safety profile of ch14.18 when administered with cytokines and isotretinoin in high-risk neuroblastoma patients after autologous stem cell transplant (ASCT).

SECONDARY OBJECTIVES:

I. To further describe and refine the event-free survival (EFS) and overall survival (OS) estimates and baseline characteristics for subjects receiving chl4.18 + cytokines + isotretinoin.

II. To further describe the safety and toxicity of chl4.18 + cytokines + isotretinoin with focus on: a) number of courses delivered per patient; b) number of dose reductions or stoppage (ch14.18 and/or interleukin \[IL\]-2 \[aldesleukin\]); and c) number of toxic deaths.

III. To further describe the immune reconstitution of patients following ASCT, based on laboratory data obtained just prior to, during, and after treatment with this regimen.

IV. To obtain correlative laboratory data to evaluate and describe mechanisms related to response, toxicity of immune activation, and allergic phenomena.

OUTLINE:

Patients receive sargramostim subcutaneously (SC) or intravenously (IV) over 2 hours on days 0-13 of courses 1, 3, and 5; monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4; and isotretinoin orally (PO) twice daily (BID) on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5. Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4. Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy

Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.

Event-free Survival (EFS) for all eligible patients enrolled on the study

Overall Survival (OS) for all eligible patients enrolled on the study

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: \> 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin

Abdominal pain (10300), course 1

Abdominal pain (10300), course 2

Abdominal pain (10300), course 3

Abdominal pain (10300), course 4

Abdominal pain (10300), course 5

Abdominal pain (10300), course 6

Allergic reaction (12000), Course 1

Allergic reaction (12000), Course 2

Allergic reaction (12000), Course 3

Allergic reaction (12000), Course 4

Allergic reaction (12000), Course 5

Allergic reaction (12000), Course 6

Anal pain (12800), Course 1

Anal pain (12800), Course 2

Anal pain (12800), Course 3

Anal pain (12800), Course 4

Anal pain (12800), Course 5

Anal pain (12800), Course 6

Anaphylaxis (13100), Course 1

Anaphylaxis (13100), Course 2

Anaphylaxis (13100), Course 3

Anaphylaxis (13100), Course 4

Anaphylaxis (13100), Course 5

Anaphylaxis (13100), Course 6

Back pain (16200), Course 1

Back pain (16200), Course 2

Back pain (16200), Course 3

Back pain (16200), Course 4

Back pain (16200), Course 5

Back pain (16200), Course 6

Capillary leak syndrome (19800) - Course 1

Capillary leak syndrome (19800) - Course 2

Capillary leak syndrome (19800) - Course 3

Capillary leak syndrome (19800) - Course 4

Capillary leak syndrome (19800) - Course 5

Capillary leak syndrome (19800) - Course 6

Chest wall pain (21400) - Course 1

Chest wall pain (21400) - Course 2

Chest wall pain (21400) - Course 3

There was one patient that did not receive treatment, represented on the baseline form as "withdrawal by patient", not included in outcome measure tabulation.

Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma	NCT03786783	Ganglioneurobla... High Risk Neuro...	Autologous Hema... Carboplatin Cisplatin Cyclophosphamid... Dexrazoxane Dinutuximab Doxorubicin Etoposide External Beam R... Isotretinoin Melphalan Sargramostim Thiotepa Topotecan Vincristine	- 30 Years	National Cancer Institute (NCI)
Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma	NCT04751383	High Risk Neuro... Recurrent Neuro... Recurrent Osteo... Refractory Neur... Resectable Oste...	Biospecimen Col... Bone Marrow Asp... Bone Marrow Bio... Computed Tomogr... Dinutuximab Magnetic Resona... Magrolimab Resection	2 Years - 35 Years	National Cancer Institute (NCI)
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma	NCT01041638	High Risk Neuro...	Aldesleukin Diagnostic Labo... Dinutuximab Isotretinoin Sargramostim	-	National Cancer Institute (NCI)
Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma	NCT03061656	High Risk Neuro...	Cyclophosphamid... Carboplatin Etoposide 131I-MIBG Thiotepa Melphalan	- 21 Years	Samsung Medical Center
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma	NCT01041638	High Risk Neuro...	Aldesleukin Diagnostic Labo... Dinutuximab Isotretinoin Sargramostim	-	National Cancer Institute (NCI)
NB2013-HR German (GPOH) / Dutch (DCOG) Trial	NCT02641782	Neuroblastoma	antibody ch14.1... GM-CSF IL-2 i.v. IL-2 s.c. Retinoic acid	18 Months - 25 Years	University of Cologne
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma	NCT03794349	High Risk Neuro... Recurrent Neuro... Refractory Neur...	Dinutuximab Eflornithine Hy... Irinotecan Hydr... Sargramostim Temozolomide	1 Year -	Children's Oncology Group
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma	NCT03794349	High Risk Neuro... Recurrent Neuro... Refractory Neur...	Dinutuximab Eflornithine Hy... Irinotecan Hydr... Sargramostim Temozolomide	1 Year -	Children's Oncology Group

Spots Global Cancer Trial Database for high risk neuroblastoma