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Therapeutic Areas: Oncology | Pediatrics/Neonatology | Neurology
Disease Category: Neuroblastoma
Location: United States, OH

Clinical Trial Details

Overview

Research Study Summary

131I-Metaiodobenzylguanidine (MIBG) with Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

Purpose

What is the purpose of this study?
The purposes of this study are:

  • To determine how many tumors get smaller after treatment with 131I-MIBG + high dose chemotherapy followed by infusion of autologous blood forming stem cells and local radiation in patients with high-risk neuroblastoma that has either relapsed or is at high risk for relapsing after standard treatment.
  • To continue to look at both the good and bad effects of 131I-MIBG and high dose chemotherapy with autologous stem cell infusion and local radiation on patients who are treated with this regimen.
  • To determine the amount of 131I-MIBG which is taken up by the tumor and if this can be related to how small the tumor gets after 131I-MIBG treatment.

Who will be included in this study?
Patients who are 1 to 29 years old at initial diagnosis who have high risk neuroblastoma may be eligible to participate in this clinical trial.

What is involved?

Participants will have the following exams, tests, and procedures completed before the study begins.

  • Stem cell collection
  • Central line
  • Physical exam
  • Tests of heart function
  • Blood tests
  • Urine tests
  • Pregnancy test
  • Tests of kidney function
  • Bone marrow tests
  • Hearing test
  • Various scans (including MIBG scan, Chest X-Ray, CT, or MRI scan)

Exams, tests, and procedures during the study are broken down in to those that are done during and after treatment with MIBG, and before admission and during transplant.

During 131I-MIBG Treatment
  • Readings to measure whole body radiation are done each day
  • No medical tests will be done while the patient is in the special room for 131I-MIBG treatment unless the doctor feels it is necessary.
After 131I-MIBG Treatment
  • MIBG scan performed 6 days after 131I-MIBG treatment. This scan would only be done if the participant did not participate in the dosimetry study.
Before being admitted for high-dose chemotherapy transplant
  • Physical exams
  • Blood tests
During transplant
  • Physical exam
  • Blood tests
  • Urine tests
  • X-rays other tests or procedures that the study doctor feels are necessary
When participants are finished with transplant, they will have the following tests done:
  • Physical exam
  • Tests of heart function
  • Blood tests
  • Urine tests
  • Tests of kidney function
  • Bone marrow tests
  • Hearing test
  • Various scans (including MIBG scan), Chest X-Ray, CT (or MRI scan)

Participants will be treated on this study until 8-12 weeks after the stem cell infusion (2-3 months) or for as long as it takes for the stem cells to produce enough normal blood cells and to recover after the transplant therapy. Participants will only be treated once with 131 I-MIBG and chemotherapy followed by stem cell infusion. They will continue to have tests and scans done to assess the status of the tumor. Blood tests to monitor thyroid and liver function will be done at 6 months, 1 year, and 2 years post transplant, and then as often as the doctor feels they are necessary. Researchers will continue to collect patient information for a lifetime.

What are the benefits?
Participants who agree to take part in this research study may not experience a direct medical benefit. Based on other experience with 131I-MIBG with or without high dose chemotherapy + stem cells in adults and children, researchers believe that this treatment may offer some benefit to patients with poorly responding or relapsed neuroblastoma by stopping the growth and spread of the disease for a time. However, each person responds differently to treatment; participants may not respond to this treatment. We do know that the information from this study will help doctors learn more about 131I-MIBG + high dose chemotherapy + stem cells as a treatment for neuroblastoma. The information learned from this research study may benefit other patients with neuroblastoma in the future.

Will I get all the facts about the study?
Parents interested in having their child participate, as well as adult patients/subjects, will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/guardian/adult subject and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian or adult subject has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects will be provided to those patients interested in knowing more about the study.

Who should I contact for more information?
To Learn more
Gender

Both Male and Female

Age

1 to 29 Years

Overall Status

Recruiting

Facility Type

N/A

Contact

Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Division of Hematology/Oncology, MLC 11013
3333 Burnet Ave.
Cincinnati, OH 45229
Phone: 513-636-2799

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 83928

Date Last Changed: July 25, 2013


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