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Radiopharmaceutical

MIBG Therapy for Cancer (MIBG Trial)

Phase 2

Waitlist Available

Led By Mark A Ranalli, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic function: Total bilirubin < 1.5 x ULN for age, SGPT (ALT) and SGOT (AST) < 10 x ULN for age

Patients must be between 12 months and 65 years at the time of enrollment

Must not have

Planned busulfan/melphalan consolidation therapy following treatment with 131I-MIBG

Prior allogeneic BMT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up response rate will be assessed at 42 days post therapy.

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is to study the effects of the radiopharmaceutical <131>I-MIBG on patients with tumors that concentrate the agent. The study will also evaluate the side effects of the therapy.

Who is the study for?

This trial is for people aged 1 to 65 with MIBG avid tumors, such as neuroblastoma. They should have recovered from previous treatments and not be pregnant or breastfeeding. Participants need a stem cell source ready for rescue in case of severe blood cell count drops due to treatment. Major organ function must be stable, and they can't have had certain prior radiation therapies or an active infection needing IV drugs.

What is being tested?

The study tests the effectiveness of <131>I-MIBG therapy on patients with new, relapsed, or resistant neuroendocrine tumors like neuroblastoma by measuring tumor response after 42 days. It also assesses safety regarding blood cell counts and other potential toxic effects. The process includes scans and various cancer evaluations before and after treatment.

What are the potential side effects?

<131>I-MIBG may cause low blood cell counts requiring stem cell reinfusion (about half at higher doses), mild non-blood related side effects, and requires special facilities due to its radioactive nature.

Eligibility Criteria

Inclusion Criteria

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

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My liver tests are within the required range.

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I am between 1 year and 65 years old.

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My kidney function is normal based on my creatinine levels.

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I don't need oxygen and I don't have trouble breathing when resting.

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My cancer did not fully respond or partially responded with a high score to initial treatment.

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I have high-risk neuroblastoma, finished initial treatment, but my cancer didn't respond well.

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I have been diagnosed with neuroblastoma, confirmed by tests.

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My condition is worsening despite treatment.

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My heart's pumping ability is normal, as confirmed by a heart scan.

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I am mostly active and expected to live for at least 2 more months.

Exclusion Criteria

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

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I am scheduled for busulfan/melphalan therapy after 131I-MIBG treatment.

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I have had a bone marrow transplant from a donor.

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There are treatments available that could potentially cure my condition.

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I have received or will receive CEM therapy close to my 131I-MIBG treatment.

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I am currently on IV medication for an infection.

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I am currently on hemodialysis.

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I have had radiation therapy to my whole body, abdomen, or liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response rate will be assessed at 42 days post therapy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~response rate will be assessed at 42 days post therapy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and response rate will be assessed at 42 days post therapy. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To determine the response rate to <131>I-MIBG treatment.

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: MIBGExperimental Treatment1 Intervention

Research participants with MIBG avid tumors

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

348 Previous Clinical Trials

5,228,467 Total Patients Enrolled

Mark A Ranalli, MDPrincipal InvestigatorNationwide Children's Hospital

~2 spots leftby Mar 2025

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