What is the mechanism of action of this treatment?

Lenalidomide, a chemotherapy agent, works by inhibiting the growth and division of tumor cells, which is crucial for controlling the spread of Neuroblastoma. Dinutuximab, a monoclonal antibody, targets specific proteins on the surface of tumor cells, interfering with their growth and spread, thereby enhancing the immune system's ability to fight the cancer. Isotretinoin, another chemotherapy drug, also inhibits tumor cell growth and division, helping to reduce the tumor burden. These treatments are important for Neuroblastoma patients as they offer multiple mechanisms to attack the cancer, potentially improving outcomes and reducing the likelihood of resistance.

What side effects are associated with this type of intervention?

The most common treatments for Neuroblastoma, including Lenalidomide, Dinutuximab, and Isotretinoin, have various side effects. Lenalidomide can cause fatigue, low blood counts, and increased risk of infections. Dinutuximab is associated with pain, fever, capillary leak syndrome, and allergic reactions. Isotretinoin may lead to dry skin, mucous membranes, and potential liver toxicity. Combining these treatments may enhance efficacy but also increases the likelihood of experiencing these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroblastoma, particularly focusing on high-risk cases. Dinutuximab, a monoclonal antibody, has been approved for use in combination with other therapies to target and interfere with tumor cell growth and spread. Isotretinoin, a retinoid, is used to inhibit tumor cell growth and division, particularly in the maintenance phase after initial treatment. While Lenalidomide is being studied in combination with Dinutuximab and Isotretinoin for its potential to inhibit tumor cell growth and division, it has not yet received FDA approval specifically for Neuroblastoma. These treatments aim to improve survival rates and reduce the risk of recurrence in pediatric patients.

What other types of research exist?

Promising novel alternatives for Neuroblastoma treatment include: 1) TRK inhibitors like Larotrectinib, which target TRK fusion-positive cancers and have shown potential in neoadjuvant settings. 2) Anti-GD2 antibodies such as Hu14.18K322A, which have been evaluated in recurrent/refractory solid tumors. 3) mTOR inhibitors like Everolimus, which have been studied for their efficacy in various pediatric tumors. These alternatives offer new mechanisms of action and potential benefits for Neuroblastoma patients.

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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

Must not have

Inability to swallow lenalidomide capsules whole; capsules of 13-isotretinoin may be opened

Patients who have an active or uncontrolled infection are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the best dose and side effects of a combination of three drugs for young patients with difficult-to-treat neuroblastoma. The drugs work together to kill or stop the growth of cancer cells, with one drug specifically targeting the cancer cells. IBL-302 has shown promise in enhancing the effects of common treatments like cisplatin, doxorubicin, and etoposide in neuroblastoma treatment.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow lenalidomide capsules whole.

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I do not have any current infections that are not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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 (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

~2240

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lenalidomide, a chemotherapy agent, works by inhibiting the growth and division of tumor cells, which is crucial for controlling the spread of Neuroblastoma. Dinutuximab, a monoclonal antibody, targets specific proteins on the surface of tumor cells, interfering with their growth and spread, thereby enhancing the immune system's ability to fight the cancer. Isotretinoin, another chemotherapy drug, also inhibits tumor cell growth and division, helping to reduce the tumor burden. These treatments are important for Neuroblastoma patients as they offer multiple mechanisms to attack the cancer, potentially improving outcomes and reducing the likelihood of resistance.