MIBG + Dinutuximab Therapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: New Approaches to Neuroblastoma Therapy Consortium

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a combination of a radioactive drug, an antibody, and possibly another drug in children with hard-to-treat neuroblastoma. The treatment works by killing cancer cells directly and helping the immune system attack them.

Eligibility Criteria

This trial is for pediatric patients with high-risk neuroblastoma, a type of cancer. They must have evidence of MIBG uptake in tumors or increased urinary catecholamines and meet specific criteria regarding their disease state (recurrent/progressive, refractory, persistent). Participants need to be recovered from prior treatments and have adequate organ function. Pregnant individuals or those unable to follow the study plan are excluded.

Inclusion Criteria

My cancer shows MIBG uptake in at least one site, confirmed within the last 28 days.

I have been diagnosed with neuroblastoma confirmed by tests.

My neuroblastoma is classified as high-risk according to COG.

See 7 more

Exclusion Criteria

I am currently receiving hemodialysis.

I have chosen not to participate in the NANT 2004-05 study.

I have had anti-GD2 therapy but not with 131I-MIBG.

See 11 more

Treatment Details

Interventions

131I-MIBG (Radiopharmaceutical)
Dinutuximab (Monoclonal Antibodies)
Vorinostat (Histone Deacetylase Inhibitor)

Trial OverviewThe trial tests a combination therapy using 131I-MIBG with dinutuximab for children with neuroblastoma that's resistant or has come back after treatment. If safe, vorinostat will be added at a certain dose level. The study uses a 'rolling 6' design to find the best dose for phase 2 trials and includes additional patient groups to confirm findings.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: 131I-MIBG with Dinutuximab and VorinostatExperimental Treatment5 Interventions

Patients will receive vorinostat on days 0-13. 131I-MIBG will be received on day 1. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab and 131I-MIBG dose will be based on the dose level assigned at the time of patient registration. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy

Group II: 131I-MIBG with DinutuximabExperimental Treatment4 Interventions

Patients will receive 131I-MIBG on day 1. Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab and 131I-MIBG dose will be based on the dose level assigned at the time of patient registration. Patient will receive GM-CSF on days 8-17 and 29-38 at 250 mcg/m2. All patients will receive autologous hematopoietic stem cell infusion on day 15 (+/- 2) of therapy

131I-MIBG is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Azedra for: