MIBG Therapy for Patients with Tumors That Absorb MIBG

Sponsor: Nationwide Children's Hospital

Sponsor score: 0

ClinicalTrials ID:NCT02378428

Provider View

This study is testing a treatment called I-131 MIBG for patients with certain types of tumors that absorb MIBG, like neuroblastoma. The goal is to see how well the treatment works and how safe it is, by checking the tumor's response and any side effects 42 days after treatment.

Patient Parameters

Program Overview

This Phase II study is for patients with tumors that absorb MIBG, such as neuroblastoma. It aims to find out how effective I-131 MIBG therapy is in shrinking these tumors 42 days after treatment. The study will also look at the safety of the treatment by monitoring side effects, especially those affecting blood cells. Patients will have various tests, like scans and blood tests, to compare their condition before and after treatment. To join, patients need to have tumors that absorb MIBG and a backup supply of their own stem cells in case of low blood cell counts after treatment. This study will help gather information for future research on I-131 MIBG therapies.

Eligibility Criteria

Inclusion Criteria

  • Age between 1 and 65 years.
  • Diagnosed with neuroblastoma or similar tumors, confirmed by tests.
  • Tumors must not have responded to previous treatments or have returned.
  • Must have tumors that absorb MIBG, confirmed by a scan within 4 weeks before joining the study.
  • If receiving more than 12 mCi/kg of I-131 MIBG, must have stem cells collected beforehand.
  • Must be in good general health with a performance score of 60% or higher and a life expectancy of at least 2 months.
  • Can join with or without additional treatment for recurring tumors, but must have recovered from any previous treatments.
  • Must meet specific blood, kidney, liver, heart, and lung function requirements.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control.
  • Breastfeeding women must agree to stop breastfeeding.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Previous bone marrow transplant from a donor.
  • Serious organ diseases that could affect treatment tolerance.
  • On dialysis.
  • Recent positive tests for Hepatitis B or C.
  • Active infections needing IV treatment, unless stable and meeting other criteria.
  • Previous total body or abdominal radiation.
  • Medical or psychological conditions that increase risk or affect compliance.
  • Patients with other curative treatment options.
  • Planned treatments with certain chemotherapy drugs within 30 days before or after I-131 MIBG therapy.

Locations

FACILITYZIPCITYSTATE
Nationwide Children's Hospital43205ColumbusOhio

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