Double-Dose radiation attack shows promise for stubborn childhood cancer
NCT ID NCT00083135
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a new approach for children with neuroblastoma that did not respond to standard treatments. It used two rapid infusions of a radioactive drug (I-MIBG) to target cancer cells, followed by a stem cell transplant to restore healthy blood cells. The goal was to find the safest dose and see if this method could control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Mar 2004
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 30 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Boston
Boston, Massachusetts, 02115, United States
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Children's Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
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Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
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UCSF Comprehensive Cancer Center
San Francisco, California, 94143, United States
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University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a drug duo outsmart resistant tumors?
- Can a Two-Drug combo outsmart returning childhood cancers?
- Can a Two-Drug combo beat tough childhood cancers?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Can a shorter chemo combo tame High-Risk neuroblastoma?
- Can a radioactive 'Smart Bomb' take down resistant childhood cancers?