Lenalidomide + Dinutuximab +/- Isotretinoin for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen by Araz Marachelian

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with neuroblastoma confirmed by tests.

My blood, kidney, liver, heart, and metabolic health meet specific criteria.

I am using effective birth control and agree to regular pregnancy tests if applicable.

Exclusion Criteria

I had a blood clot before turning 40, not due to a central line.

I cannot swallow lenalidomide capsules whole.

I have chosen not to participate in the NANT 2004-05 study, or my institution is exempt.

Participant Groups

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.

Group I: Treatment (lenalidomide, dinutuximab, isotretinoin) Experimental Treatment 5 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.

Dinutuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Unituxin for:

• Neuroblastoma

🇪🇺 Approved in European Union as Dinutuximab for:

• High-risk neuroblastoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UNC Lineberger Comprehensive Cancer Center Chapel Hill, NC

University of Chicago Comer Children's Hospital Chicago, IL

Dana-Farber Cancer Institute Boston, MA

C S Mott Children's Hospital Ann Arbor, MI

More Trial Locations

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References