← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

MIBG Trial 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.Check my eligibility

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.See study design

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.

MIBG Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My liver tests are within the required range.

Select...

I am between 1 year and 65 years old.

Select...

My kidney function is normal based on my creatinine levels.

Select...

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

Select...

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

Select...

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

Select...

I have been diagnosed with neuroblastoma, confirmed by tests.

Select...

My condition is worsening despite treatment.

Select...

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

Select...

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

MIBG Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

MIBG Trial Design

1Treatment groups

Experimental Treatment

Group I: MIBGExperimental Treatment1 Intervention

Research participants with MIBG avid tumors

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,438 Total Patients Enrolled

Mark A Ranalli, MDPrincipal InvestigatorNationwide Children's Hospital

Frequently Asked Questions

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

Can elderly individuals aged 75 or more participate in this investigation?

"This study is recruiting participants aged between 12 months and 65 years."

Answered by AI

Is there any way I can partake in this trial?

"To gain entry into this research trial, prospective participants must have tumors and be between twelve months and sixty-five years of age. Approximately 65 candidates are being sought out for the study."

Answered by AI

Has the FDA sanctioned MIBG for clinical use?

"Due to the lack of efficacy data, MIBG was rated a 2 on our safety scale. This is attributable to its Phase 2 trial status which suggests some evidence for safety but no proof of efficiency."

Answered by AI

What is the principal application of MIBG?

"Paraganglioma can be addressed with the use of MIBG. Additionally, this radionuclide therapy is effective at treating neoplasms metastasis, primary neuroblastomas, and inoperable metastatic iobenguane-scan positive pheochromocytomas."

Answered by AI

Is there still an opportunity for participants to join this scientific experiment?

"This clinical trial has since concluded, with the initial posting of March 1st 2014 and its last update on September 12th 2023. Other trials presently recruiting patients who have tumors are available as well as 5 studies involving MIBG treatments."

Answered by AI

How many people are involved in this trial at present?

"At present, this clinical trial is not recruiting new patients. The study was initially posted on March 1st 2014 and the latest update was made on September 12th 2023. If you are seeking alternative trials, there are currently one actively enrolling participants with tumors and five other MIBG studies that need volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MIBG Therapy for Patients With MIBG Avid Tumors

2014. "MIBG Therapy for Patients With MIBG Avid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02378428.

All > Paid Studies Ohio