Loading clinical trials...

131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma | Clinical Trials | Clareo Health

NO_LONGER_AVAILABLE

131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma

NCT03649438•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

This expanded access is the best available therapy/compassionate use designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are not eligible for therapies of higher priority. Patients may receive a range of doses depending on stem cell availability and tumor involvement of bone marrow. Response rate, toxicity, and time to progression and death will be evaluated.

Detailed Description

Primary Objective is to provide access to therapy with 131I-MIBG for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma. Secondary Objectives are to (1) assess disease response to 131I-MIBG therapy for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma; (2) gain more information about the toxicities of 131I-MIBG therapy; and (3) assess improvement of symptoms, including pain and fatigue, for patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are receiving 131I-MIBG therapy.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis:
•Relapsed/refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical neuroblastoma cells in the bone marrow
•Metastatic pheochromocytoma
•Age \>1 year and able to cooperate with radiation safety restrictions during therapy period
•Karnofsky or Lansky performance status of ≥ 50%
•Life expectancy: patients must have a life expectancy of at least 8 weeks
•Disease status: Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any phase of standard therapy (any new lesion or an increase in size \>25% of a pre-existing lesion). Patients may enter this study with or without re-induction therapy for recurrent tumor.
•Disease must be evaluable by MIBG scan. A positive MIBG scan must be present within 8 weeks prior to study entry and subsequent to any intervening therapy. If the patient has only one MIBG positive lesion and that lesion was radiated, a biopsy must be done at least 4 weeks after radiation was completed and must show viable neuroblastoma.
•Stem Cells: If a patient does not have a hematopoietic stem cell product available for re-infusion after MIBG treatment, they may not receive a 131IMIBG dose \>12 mCi/kg. Patients must have a hematopoietic stem cell product available for re-infusion after MIBG treatment at doses of \> 12 mCi/kg. The minimum quantity for peripheral blood stem cells is 1.5 x 106 CD34+ cells/kg (optimum \> 2 x 106 CD34+ cells/kg). The minimum dose for bone marrow is 1.0 x 108 mononuclear cells/kg (optimum \>2.0 x 108 mononuclear cells/kg).
•Stem cell source: The patients on this protocol will have autologous PBSCs available.
+14 more criteria

Exclusion Criteria

•Patients with disease of any major organ system that would compromise their ability to withstand therapy.
•Because of the teratogenic potential of the study medication, no patients who are pregnant or lactating will be allowed. Patients of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus.
•Known allergy to any of the agents or their ingredients used in this study.
•Patients who are on hemodialysis
•Patients with untreated positive blood cultures or progressive infections as assessed by radiographic studies
•Patients who have had prior treatment with 131I-MIBG who do not meet the re-treatment criteria.
•In patients with metastatic pheochromocytoma, screening urinalysis required prior to study enrollment. If random collection urine specimen is positive for proteinuria, patients must have 24-hour urine protein determination. Patients with metastatic pheochromocytoma are excluded if 24-hour urine protein is above the institutional upper limit of normal.
•Patients with known MIBG-avid parenchymal brain metastases are excluded.

Locations (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Last Updated

December 11, 2024

Conditions

Relapsed NeuroblastomaMetastatic Pheochromocytoma

Interventions

131 I-Metaiodobenzylguanidine

DRUG

Potassium Iodide

DRUG

G-csf

DRUG

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

NCT06721689

Refractory Solid TumorsRelapsed Solid Tumors+4 more

View study

WITHDRAWNPHASE1

Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2

NCT03209869

NeuroblastomaRelapsed Neuroblastoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma

Inclusion Criteria

Exclusion Criteria

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors

Treatment of Relapsed or Refractory Neuroblastoma and Osteosarcoma With Expanded Haploidentical NK Cells and Hu14.18-IL2

DNA Vaccination Against Neuroblastoma

Dovitinib in Neuroendocrine Tumors

Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors