Completed

I-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion For Refractory Neuroblastoma

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What is being tested

Data Collection

Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

From 1 to 30 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorChildren's Hospital Los Angeles
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma. * Determine the number of days after stem cell transplantation to achieve absolute neutrophil count ≥ 500/mm\^3 for 3 days and platelet count ≥ 20,000/mm\^3 for 3 days (without transfusions) in patients treated with this regimen. Secondary * Determine the response rate in patients treated with this regimen, based on lesions measurable by CT or MRI at study entry, patients with \^131I-MIBG scan-positive lesions only, and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology. * Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen. * Correlate, if possible, TP53 mutations with response in patients with accessible bone marrow tumor treated with \^131I-MIBG. OUTLINE: This is a dose-escalation, multicenter study. * Iodine I 131 metaiodobenzylguanidine (131I-MIBG) therapy: Patients receive\^131I-MIBG IV over 2 hours on days 0 and 14. Cohorts of 3-6 patients receive escalating doses of \^131I-MIBG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Stem cell transplantation therapy: Patients undergo autologous peripheral blood stem cell transplantation on day 28. Patients receive filgrastim (G-CSF) IV over 1 hour OR subcutaneously daily beginning on day 28 and continuing until blood counts recover. Patients are followed every 3 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study within 2 years.

Official TitleI-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion For Refractory Neuroblastoma 
NCT00083135
Principal SponsorChildren's Hospital Los Angeles
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, Neuroepithelial

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma * Confirmed by at least 1 of the following methods: * Histology * Clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites * High-risk disease * Poor response to induction therapy OR relapse defined by any of the following: * No response, stable disease, or mixed response after a minimum of 3 prior courses of chemotherapy * More than 100 tumor cells per 10\^5 nucleated cells on bone marrow immunocytology after at least 3 prior courses of chemotherapy * Progressive disease at any time during or after therapy * Patients with massive bone marrow invasion (more than 50% replacement of bone marrow by tumor cells) are allowed * Must have positive iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) within the past 6 weeks or subsequent to any other prior antitumor therapy delivered within the past 6 weeks * Must meet the following criteria for minimum number of autologous stem cells: * Unpurged peripheral blood stem cells (PBSC) * Minimum of 1,500,000/mm\^3 CD34-positive cells/kg * Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology * PBSC purged with immunomagnetic beads * Minimum of 1,000,000/mm\^3 viable CD34-positive cells/kg * Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology * CD34-positive selected PBSC products are not allowed * Patients who had PBSC collected previously with no immunocytological testing available may use those products provided bone marrow is tumor free by bilateral bone marrow aspirate AND biopsy for morphology is performed within 4 weeks before PBSC collection * Patients with no tumor involvement in bone marrow at diagnosis and PBSC collection before any disease progression do not require documentation of negative bone marrow morphology PATIENT CHARACTERISTICS: Age * 1 to 30 Performance status * ECOG 0-2 Life expectancy * Less than 1 year Hematopoietic * Absolute neutrophil count ≥ 500/mm\^3 * Platelet count ≥ 50,000/mm\^3 (without transfusion) * Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic * AST and ALT ≤ 5 times normal * Bilirubin \< 2 times normal Renal * Creatinine ≤ 1.5 mg/dL * Glomerular filtration rate OR 12-hour creatinine clearance ≥ 60 mL/min/1.73m\^2 Cardiovascular * Ejection fraction ≥ 55% by echocardiogram or MUGA OR * Fractional shortening ≥ 30% OR above lower limit of normal by echocardiogram Pulmonary * Normal lung function * No dyspnea at rest * No exercise intolerance * No oxygen requirement Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to cooperate physically and psychologically with radiation isolation * No disease of any major organ system that would preclude study participation * No active infection requiring antivirals, antibiotics, or antifungals * No weight that would require exceeding a maximum total allowable dose of \^131I-MIBG PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior biologic or other non-myelosuppressive therapy Chemotherapy * See Disease Characteristics * At least 2 weeks since prior chemotherapy * More than 3 months since prior myeloablative therapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 6 months since prior craniospinal, total abdominal, or whole lung radiotherapy * At least 2 weeks since prior radiotherapy to any site * No prior total body irradiation * No prior radiotherapy to \> 25% of bone marrow * No prior \^131I-MIBG Surgery * Not specified Other * Recovered from all prior therapy * Concurrent antifungal therapy allowed provided culture and biopsy are negative in suspected radiographic lesions * Prior re-induction therapy for recurrent tumor allowed * No concurrent antiretroviral therapy for HIV-positive patients * No concurrent hemodialysis

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

Children's Hospital Los Angeles

Los Angeles, United StatesSee the location
Suspended

UCSF Comprehensive Cancer Center

San Francisco, United States
Suspended

Indiana University Cancer Center

Indianapolis, United States
Suspended

Children's Hospital Boston

Boston, United States
Completed7 Study Centers