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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Who Are Feasibility "Failure"

Percentage of Participants With Unacceptable Toxicity

Secondary outcome measures

Event-free Survival

Overall Survival

Response Rate

Other outcome measures

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

83%

Diarrhoea

58%

Nausea

50%

Back pain

42%

Decreased appetite

42%

Abdominal pain

42%

Vomiting

33%

Asthenia

33%

Neutropenia

33%

Constipation

33%

Cough

25%

Anaemia

25%

Fatigue

25%

Hypomagnesaemia

25%

Pain in extremity

17%

Dehydration

17%

Headache

17%

Arthralgia

17%

Pyrexia

17%

Diarrhea

17%

Abdominal pain upper

17%

Musculoskeletal chest pain

17%

Neuropathy peripheral

17%

Rash

Acute kidney injury

Stomatitis

Chest pain

Hypokalaemia

Agitation

Epistaxis

Pneumonia

Atrial fibrillation

Gastrooesophageal reflux disease

Chest discomfort

Septic shock

Dysphonia

Chronic obstructive pulmonary disease

Rhinorrhoea

Acute respiratory failure

Respiratory tract congestion

Dysphagia

Abdominal pain lower

Dry mouth

Flatulence

Non-cardiac chest pain

Discomfort

Upper respiratory tract infection

Bronchitis

Palmar erythema

Clostridium difficile colitis

Blood creatinine increased

Peripheral arterial occlusive disease

Weight decreased

Neutrophil count decreased

Platelet count decreased

Clostridium test positive

Haemoglobin decreased

Hypocalcaemia

Hypercalcaemia

Hypercholesterolaemia

Hypertriglyceridaemia

Musculoskeletal pain

Flank pain

Muscular weakness

Neck pain

Restless legs syndrome

Anxiety

Confusional state

Productive cough

Alopecia

Erythema

Livedo reticularis

Hypotension

Hypertension

Flushing

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Dinutuximab + Irinotecan

Part 2: Dinutuximab + Irinotecan

Part 2: Irinotecan

Part 2: Topotecan

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

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Cyclophosphamide

1995

Completed Phase 3

~3770

Dexrazoxane

2016

Completed Phase 2

~80

External Beam Radiation Therapy

2006

Completed Phase 3

~3070

Melphalan

2008

Completed Phase 3

~1500

Sargramostim

2008

Completed Phase 4

~710

Thiotepa

2008

Completed Phase 3

~2150

Vincristine

2003

Completed Phase 4

~2910

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~1730

Etoposide

2010

Completed Phase 3

~2440

Dinutuximab

2009

Completed Phase 3

~710

Doxorubicin

2012

Completed Phase 3

~7940

Topotecan

2017

Completed Phase 3

~2400

Isotretinoin

2019

Completed Phase 4

~3520

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,625 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,686 Patients Enrolled for Neuroblastoma

Sara M FedericoPrincipal InvestigatorChildren's Oncology Group

1 Previous Clinical Trials

478 Total Patients Enrolled

1 Trials studying Neuroblastoma

478 Patients Enrolled for Neuroblastoma

Media Library

Carboplatin (Cytotoxic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03786783 — Phase 2

Neuroblastoma Research Study Groups: Treatment(chemotherapy, dinutuximab, sargramostim, ASCT, EBRT)

Neuroblastoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what circumstances is Dinutuximab typically administered?

"Dinutuximab is commonly prescribed to treat kaposi's sarcoma associated with AIDS, yet it can also be efficacious in battling merkel cell cancer and leukemia first line."

Answered by AI

Is this particular experimentation being conducted across multiple locations within the state?

"Currently, this trial is running in 7 geographically dispersed locations which include New york, Pittsburgh and Memphis. If you are interested in enrolling then it is ideal to select a site close to home so as not to add any undue travel burdens."

Answered by AI

Has a similar research been conducted previously?

"Currently, there are 2,213 ongoing Dinutuximab studies occurring in 4052 cities and 89 nations. The initial trial of this medication was sponsored by Alfacell back in 1997; the Phase 3 study included 300 participants before concluding. Since its conception, a total of 3,499 trials have been finalized."

Answered by AI

Are the researchers for this project currently accepting new participants?

"The details on clinicaltrials.gov reveal that this particular medical trial is not currently enrolling patients; the protocol was first posted in January 14th 2019, with its last update taking place in September 1st 2022. Nonetheless, there are a plethora of other studies recruiting individuals at present - 2374 to be exact."

Answered by AI

Is Dinutuximab a novel therapeutic option with existing research?

"Dinutuximab was first researched in 1997 at the Spectrum Health Hospital - Butterworth Campus. Since then, 3499 trials have been completed and there are currently 2213 active studies taking place across New york City."

Answered by AI

What is the highest possible figure of individuals taking part in this trial?

"The recruiting period for this clinical trial has expired. It was first posted on January 14th, 2019 before being updated lastly on September 1st 2022. If you are searching for other trials, 161 studies with ganglioneuroblastoma and 2,213 involving dinutuximab currently require participant enrolment."

Answered by AI

Has Dinutuximab been given the green light by the FDA?

"Dinutuximab, which is partaking in a Phase 2 trial, has been estimated to be of moderate safety with a score of 2. This reflects the existing data supporting its security but lack thereof for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03786783.

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