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Retinoid

Isotretinoin +/- Immunotherapy for Neuroblastoma

Phase 3
Waitlist Available
Led By Alice L Yu
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
All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include:
All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include: Following treatment per A3973 protocol, Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol, Following treatment per CCG3891, Following treatment on New Approaches to Neuroblastoma Therapy (NANT) 2001-02, Enrollment on or following treatment per ANBL02P1, Enrollment on or following treatment per ANBL07P1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Summary

This trial will compare isotretinoin alone to isotretinoin with dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating patients with neuroblastoma.

Who is the study for?
This trial is for patients with high-risk neuroblastoma who have completed intensive induction, stem cell transplant, and radiotherapy. Eligible participants must not have had prior anti-GD2 antibody therapy, should be able to perform daily activities at least half of the time (>=50% performance score), expect to live more than 2 months, and have adequate organ function. They must also agree to use birth control if applicable and cannot be breastfeeding.
What is being tested?
The study tests whether adding dinutuximab (a monoclonal antibody), aldesleukin (stimulates white blood cells), and sargramostim (boosts immune system) to isotretinoin chemotherapy improves outcomes in neuroblastoma post-stem cell transplant compared to isotretinoin alone. It's a phase III trial where some patients are randomly chosen to receive the additional drugs.
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation or allergy-like symptoms due to dinutuximab; fatigue; changes in blood pressure or heart rate from aldesleukin; bone pain or fever from sargramostim; dry skin or lips, nosebleeds, joint pains from isotretinoin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed therapy for my cancer, including intensive treatment and a stem cell transplant.
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I've completed therapy for neuroblastoma, including intensive treatments and possibly surgery.
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My kidney function is within the required range for my age and gender.
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My lung function tests are above 60% of what's expected, or I'm a child without breathing issues.
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I have never received GD2 antibody therapy.
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I can do most activities and my doctor thinks I have at least 2 months to live.
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My kidney function is normal or near normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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
Event-Free Survival (EFS)
Secondary study objectives
Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial
Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0
Number of Courses of Therapy Delivered
+2 more
Other study objectives
Average Level of HACA
Cardiac Repolarization
Change in MRD
+8 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
33%
Infusion Related Reaction
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
17%
Sinusitis
17%
Tumor Lysis Syndrome
17%
Interoperative Hemorrhage
17%
Platelet count decreased
17%
Febrile neutropenia
17%
Infusion related reaction
17%
Upper respiratory infection
17%
Otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Phase 2 and MTD (800 mg Entospletinib Daily)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)Experimental Treatment7 Interventions
Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive immunotherapy comprising sargramostim SC or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.
Group II: Arm I (isotretinoin) (closed to accrual as of 4/16/2009)Active Control4 Interventions
Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive isotretinoin PO BID for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Dinutuximab
2009
Completed Phase 3
~710
Isotretinoin
2019
Completed Phase 4
~3520
Sargramostim
2006
Completed Phase 4
~880

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,009,388 Total Patients Enrolled
206 Trials studying Neuroblastoma
52,276 Patients Enrolled for Neuroblastoma
Alice L YuPrincipal InvestigatorChildren's Oncology Group

Media Library

Isotretinoin (Retinoid) Clinical Trial Eligibility Overview. Trial Name: NCT00026312 — Phase 3
Neuroblastoma Research Study Groups: Arm I (isotretinoin) (closed to accrual as of 4/16/2009), Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
Neuroblastoma Clinical Trial 2023: Isotretinoin Highlights & Side Effects. Trial Name: NCT00026312 — Phase 3
Isotretinoin (Retinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00026312 — Phase 3
~61 spots leftby Oct 2025
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