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Radioactive cocktail shows promise against tough childhood cancer

NCT ID NCT00253435

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a combination of a radioactive drug (MIBG), intensive chemotherapy, and a stem cell transplant in 50 children with relapsed or hard-to-treat neuroblastoma. The goal was to see if this approach could shrink tumors and improve survival. The treatment aims to deliver radiation directly to cancer cells while using high-dose chemo to kill remaining cells, followed by a stem cell rescue to restore blood cell production.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Iodine I 131 metaiodobenzylguanidine (MIBG) plus carboplatin, etoposide, melphalan, and radiation
What this could lead to
If it works, this could offer a more effective treatment option for children with hard-to-treat neuroblastoma, potentially improving response rates and survival.
What could go wrong
This is a small, early-phase trial (50 patients) with no control group, so results may not apply broadly. The treatment involves high-dose chemotherapy and radiation, which can cause severe side effects like infection and organ damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Start date

Sep 2005

Finished

Dec 2013

Lead sponsor

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

1 year to 29 years

Sex

Anyone

Healthy volunteers

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

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 relapsed or refractory neuroblastoma * Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites * High-risk neuroblastoma must meet one of the following: * Progressive disease prior to or after completion of induction therapy * Mixed response or no response after completion of 4 courses of induction therapy * Partial response after 4 courses of induction therapy allowed provided no prior participation in COG-A3973 or other phase III COG trials * Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions) PATIENT CHARACTERISTICS: Performance status * Lansky 60-100% OR * Karnofsky 60-100% Life expectancy * At least 2 months Hematopoietic * Hemoglobin ≥ 10 g/dL * Absolute neutrophil count ≥ 750/mm\^3 * Platelet count ≥ 50,000/mm\^3 (if no marrow involvement by morphologic exam/no transfusion allowed) (\> 20,000/mm\^3 if metastatic tumor involvement of marrow by morphologic exam/transfusion allowed) Hepatic * Bilirubin \< 1.3 mg/dL * SGOT and SGPT \< 5 times normal * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Glomerular filtration rate or creatinine clearance ≥ 60 ml/min * Creatinine ≤ 1.5 times normal for age as follows: * 0.8 mg/dL (for patients ≤ 5 years of age) * 1.0 mg/dL (for patients 6 to 10 years of age) * 1.2 mg/dL (for patients 11 to 15 years of age) * 1.5 mg/dL (for patients \> 15 years of age) Cardiovascular * Ejection fraction ≥ 55% by echocardiogram or radionuclide MUGA OR * Fractional shortening ≥ 27% by echocardiogram Pulmonary * Normal lung function defined as no dyspnea at rest and no oxygen requirement OR measured oxygen saturation \> 93% on room air Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No disease of any major organ system that would preclude study compliance * No concurrent hemodialysis * No active infection requiring IV antivirals, antibiotics, or antifungals (patients on antifungal therapy are eligible provided they are culture- and biopsy-negative in suspected residual radiographic lesions) * Patient weight within limits to receive ≤ maximum total allowable dose of \^131I-MIBG PRIOR CONCURRENT THERAPY: Biologic therapy * No prior myeloablative transplantation * Prior submyeloablative transplantation allowed at discretion of principal investigator * More than 3 weeks since prior biologic therapy Chemotherapy * More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for mitomycin C or nitrosoureas) * No prior melphalan therapy with a total dose of \> 100 mg/m\^2 Radiotherapy * See Disease Characteristics * At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy) * No prior total body irradiation * No prior iodine I 131 MIBG (\^131I-MIBG) * No prior total abdominal or whole liver radiotherapy * No prior local radiotherapy, including any of the following: * 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed) * 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver Other * Recovered from all prior therapy * No medications with a potential interference of \^131I-MIBG uptake 1 week before and 2 weeks after completion of \^131I-MIBG

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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

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

    Atlanta, Georgia, 30322, United States

  • C.S. Mott Children's Hospital at University of Michigan Medical Center

    Ann Arbor, Michigan, 48109-0286, United States

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318, United States

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027-0700, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039, United States

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104, United States

  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, 94304, United States

  • Morgan Stanley Children's Hospital of New York-Presbyterian

    New York, New York, 10032, United States

  • Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

    Houston, Texas, 77030-2399, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143, United States

  • University of Chicago Comer Children's Hospital

    Chicago, Illinois, 60637, United States

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164, United States

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