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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: 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

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

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

Secondary outcome measures

Event-Free Survival (EFS)

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

+3 more

Other outcome measures

Average Level of HACA

Cardiac Repolarization

Change in MRD

+8 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

65%

Infusion related reaction

59%

Neutrophil count decreased

41%

Upper respiratory infection

29%

Aspartate aminotransferase increased

29%

Platelet count decreased

24%

Alanine aminotransferase increased

18%

Sinusitis

18%

Urinary tract infection

12%

Tooth infection

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 and MTD (800 mg Entospletinib Daily)

Phase 1, Dose 1 (400 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

2008

Completed Phase 4

~710

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,931,704 Total Patients Enrolled

205 Trials studying Neuroblastoma

52,279 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

Frequently Asked Questions

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

Out of the total number of patients that could be enrolled, how many have chosen to participate in this research?

"Unfortunately, this study is not currently looking for more participants. The trial was originally posted on October 18th 2001 but was most recently updated on October 15th 2022. However, there are 166 other trials related to neuroblastoma and 124 different Pharmacological Studies that are actively admitting new patients."

Answered by AI

What do people use Pharmacological Study to treat?

"Severe infection is most commonly treated with pharmacological study. Pharmacological study can also help manage other conditions such as lymphoma, hodgkins, metastatic melanoma, and bone marrow transplantation."

Answered by AI

How many different locations are conducting this trial?

"In addition to Ascension Saint Vincent Indianapolis Hospital in Indianapolis, Indiana, Maine Children's Cancer Program in Scarborough, Maine, and Overlook Hospital in Summit, New jersey this clinical trial is also enrolling at 100 other locations."

Answered by AI

Are researchers still looking for participants for this experiment?

"From what is published on clinicaltrials.gov, it appears as if this study is not enrolling patients at the moment. This trial was initially posted on October 18th, 2001 and has since been edited on October 15th, 2020. There are other 290 trials that are currently open for enrollment."

Answered by AI

Are there other examples where this drug has been studied?

"There are currently 124 clinical trials underway to study the efficacy of this medication. Of these, 12 have progressed to Phase 3 testing. The majority of Pharmacological Study's clinical trials are based in Tampa, Florida; however, there are 2409 total locations running these sorts of tests."

Answered by AI