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Monoclonal Antibodies

Lenalidomide + Dinutuximab +/- Isotretinoin for Neuroblastoma

Phase 1

Waitlist Available

Led By Araz Marachelian

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

Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines

Lansky (=< 16 years) or Karnofsky (> 16 years) score of at least 50

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing lenalidomide, dinutuximab, and isotretinoin to treat neuroblastoma. The trial will test different doses of the drugs to see what works best with the least amount of side effects.

Who is the study for?

This trial is for young patients with neuroblastoma that's either not responding to treatment or has come back. They should have had some prior treatments, meet specific blood and organ function criteria, and not be on other cancer treatments. Females of childbearing age must test negative for pregnancy and both genders must use effective contraception.Check my eligibility

What is being tested?

The study tests the safety and best dose of lenalidomide combined with dinutuximab, with or without isotretinoin in children with tough-to-treat neuroblastoma. It aims to see how these drugs can stop tumor growth by killing cells or preventing them from dividing or spreading.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to monoclonal antibodies like dinutuximab, issues caused by chemotherapy agents such as lenalidomide (like low blood counts), skin problems from isotretinoin, fatigue, digestive troubles, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with neuroblastoma confirmed by tests.

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I am mostly capable of self-care with some assistance.

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I have recovered from side effects of my previous cancer treatments.

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My condition is high-risk neuroblastoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Maximum tolerated dose defined as the highest dose level tested at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) graded using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) criteria, version 4.0

Recommended phase II dose

Secondary outcome measures

Changes in TaqMan low density array (TLDA) scores

Changes in levels of HACA (or other genotype) and tumor response

Changes in the levels of T cells, natural killer (NK) cells, monocytes, cytokines, and chemokines

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, dinutuximab, isotretinoin)Experimental Treatment5 Interventions

Patients receive lenalidomide PO QD on days 1-21, dinutuximab IV over 10 hours on days 8-11, and isotretinoin PO BID on days 15-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dinutuximab

2009

Completed Phase 3

~710

Isotretinoin

2019

Completed Phase 4

~3520

Lenalidomide

2005

Completed Phase 3

~1480

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,126 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,701 Patients Enrolled for Neuroblastoma

Araz MarachelianPrincipal InvestigatorNew Approaches to Neuroblastoma Treatment (NANT)

Media Library

Neuroblastoma Research Study Groups: Treatment (lenalidomide, dinutuximab, isotretinoin)

Neuroblastoma Clinical Trial 2023: Dinutuximab Highlights & Side Effects. Trial Name: NCT01711554 — Phase 1

Dinutuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01711554 — Phase 1

Frequently Asked Questions

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

Has pharmacological research been conducted previously?

"Currently, there are 294 active trials researching Pharmacological Study. Of these investigations, 62 have advanced to Phase 3. Although the majority of research sites for this therapy is based in Chicago, Illinois, a total of 14382 locations across the world are hosting studies on it."

Answered by AI

How many locations are participating in the implementation of this trial?

"Patients looking to participate in this clinical trial can find locations at the Hospital for Sick Children in Toronto, Cincinnati Children's Hospital Medical Center in Cincinnati, and Dana-Farber Cancer Institute in Boston. Additionally, there are 12 other recruiting sites nationwide."

Answered by AI

How many participants are involved in this research project?

"At the moment, this trial is not accepting any further participants; it was initially posted on February 4th 2013 and last edited September 20th 2022. If you're looking for other trials to join, there are 1167 studies recruiting those with relapsed symptoms and 294 Pharmacological Studies that are actively seeking patients."

Answered by AI

Is it possible to join this trial at the present time?

"According to the clinicaltrials.gov record, this trial is not presently calling for participants; its first post was on April 2nd 2013 and it was last modified in September 20th 2022. Nevertheless, 1461 other ongoing trials are actively recruiting patients currently."

Answered by AI

In what cases is Pharmacological Study generally employed?

"When at least two chemotherapy regimens have been unsuccessful, Pharmacological Study can be utilized as a potential treatment. It has also proven to improve outcomes for amyloidosis, neuroblastoma (nb), and sezary syndrome patients."

Answered by AI

What are the intended outcomes of this research project?

"The primary endpoint of this trial, which will be assessed over up to 28 days, is the Maximum Tolerated Dose (MTD) calculated as the highest dose level attempted where 0 or 1 out 6 patients experience a side effect graded using NCI's Common Toxicity Criteria for Adverse Events. Secondary objectives include tracking changes in HACA levels and tumor response through summary statistics such as means/medians/ranges; visualizing associations between dosage and toxicity via scatter plots; measuring Event-Free Survival (EFS); and assessing Overall Survival with Kaplan-Meier charts."

Answered by AI