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Cytotoxic Agent

Immunotherapy + Chemotherapy for High-Risk Neuroblastoma

Phase 2
Waitlist Available
Led By Sara M Federico
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy and chemotherapy in patients with high-risk neuroblastoma to see if it is more effective than chemotherapy alone.

Who is the study for?
This trial is for children and young adults with high-risk neuroblastoma or ganglioneuroblastoma, confirmed by pathology analysis or bone marrow clumps with elevated urinary catecholamines. Participants must have certain heart function levels, adequate liver function, and kidney clearance rates. They should not have had extensive prior treatments except under specific circumstances and must be able to undergo stem cell collection. Pregnant females, patients over 18 months with non-amplified MYCN regardless of other features, those on immunosuppressants (except for allergies/adrenal therapy), breastfeeding females, and sexually active individuals not using contraception are excluded.
What is being tested?
The study tests the effectiveness of dinutuximab combined with sargramostim alongside a chemotherapy regimen before a stem cell transplant in treating high-risk neuroblastoma. The chemotherapy includes cisplatin, etoposide, vincristine, doxorubicin among others. This approach aims to improve immune response against cancer cells while making space in the bone marrow for new blood-forming cells.
What are the potential side effects?
Potential side effects include reactions related to the immune system's enhancement by dinutuximab and sargramostim such as fever or pain at injection site; effects from chemotherapy like nausea/vomiting; hair loss; mouth sores; increased risk of infections due to low white blood cell counts; organ damage risks from drugs like doxorubicin (heart) and cisplatin (kidneys); plus general fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Are Feasibility "Failure"
Percentage of Participants With Unacceptable Toxicity
Secondary study objectives
Event-free Survival
Overall Survival
Response Rate
Other study objectives
Immune Environment (Gene Expression; Immune Effector Cells, Activities and Signaling Molecules; Immune Target Expression)
Incidence of Natural Killer (NK) Receptor NKp30 Isoforms
Incidence of Naturally Occurring Anti-glycan Antibodies
+2 more

Side effects data

From 2020 Phase 2 & 3 trial • 483 Patients • NCT03098030
66%
Anaemia
51%
Neutropenia
28%
Asthenia
26%
Decreased appetite
26%
Neutrophil count decreased
25%
Nausea
25%
Thrombocytopenia
20%
Platelet count decreased
18%
Fatigue
16%
White blood cell count decreased
15%
Diarrhoea
15%
Pyrexia
15%
Constipation
15%
Dyspnoea
14%
Leukopenia
11%
Alopecia
10%
Hyperglycaemia
10%
Abdominal pain
10%
Cough
10%
Pneumonia
9%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
7%
Stomatitis
7%
Back pain
7%
Vomiting
7%
Dizziness
7%
Anemia
6%
Blood alkaline phosphatase increased
6%
Non-cardiac chest pain
6%
Lymphocyte count decreased
6%
Abdominal pain upper
6%
Blood lactate dehydrogenase increased
6%
Hypotension
5%
Hypomagnesaemia
5%
Hypokalaemia
5%
Headache
5%
Arthralgia
5%
Febrile neutropenia
3%
Muscular weakness
3%
Productive cough
3%
Pain in extremity
3%
Bronchitis
3%
Musculoskeletal chest pain
3%
Hypertension
2%
Haemoglobin decreased
2%
Musculoskeletal pain
2%
Hyponatraemia
2%
Neck pain
2%
Myalgia
2%
Confusional state
2%
Upper respiratory tract infection
2%
Anxiety
2%
Small cell lung cancer
2%
Pleural effusion
2%
Chronic obstructive pulmonary disease
2%
Pulmonary embolism
1%
Hypocalcaemia
1%
Respiratory tract infection
1%
Gastrooesophageal reflux disease
1%
Hypertriglyceridaemia
1%
Diarrhea
1%
Rash
1%
Klebsiella sepsis
1%
Blood creatinine increased
1%
Hypoxia
1%
Cardiac failure
1%
Dehydration
1%
Acute myocardial infarction
1%
Chest pain
1%
Atrial flutter
1%
Dyskinesia
1%
Ejection fraction decreased
1%
Pyelonephritis
1%
Acute kidney injury
1%
Dry mouth
1%
Dysphonia
1%
Death
1%
Troponin I increased
1%
Epistaxis
1%
Febrile bone marrow aplasia
1%
Supraventricular tachycardia
1%
Acute coronary syndrome
1%
Neutropenic colitis
1%
Herpes zoster
1%
Pain
1%
Hypercholesterolaemia
1%
Leukocytosis
1%
Pleuritic pain
1%
Malignant pleural effusion
1%
Metastases to central nervous system
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Topotecan
Part 2: Dinutuximab + Irinotecan
Part 1: Dinutuximab + Irinotecan
Part 2: Irinotecan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment(chemotherapy, dinutuximab, sargramostim, ASCT, EBRT)Experimental Treatment15 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Cyclophosphamide
2010
Completed Phase 4
~2310
Dexrazoxane
2016
Completed Phase 2
~80
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Melphalan
2008
Completed Phase 3
~1500
Thiotepa
2008
Completed Phase 3
~2120
Vincristine
2003
Completed Phase 4
~2970
Sargramostim
2006
Completed Phase 4
~880
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~2090
Etoposide
2010
Completed Phase 3
~2960
Dinutuximab
2009
Completed Phase 3
~710
Doxorubicin
2012
Completed Phase 3
~8030
Topotecan
2017
Completed Phase 3
~2460
Isotretinoin
2019
Completed Phase 4
~3520

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,986 Total Patients Enrolled
11 Trials studying Ganglioneuroblastoma
12,312 Patients Enrolled for Ganglioneuroblastoma
Sara M FedericoPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
478 Total Patients Enrolled
1 Trials studying Ganglioneuroblastoma
478 Patients Enrolled for Ganglioneuroblastoma

Media Library

Carboplatin (Cytotoxic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03786783 — Phase 2
Ganglioneuroblastoma Research Study Groups: Treatment(chemotherapy, dinutuximab, sargramostim, ASCT, EBRT)
Ganglioneuroblastoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03786783 — Phase 2
Carboplatin (Cytotoxic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03786783 — Phase 2
~6 spots leftby Nov 2025
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