New oral drug cocktail shows promise for kids with resistant neuroblastoma
NCT ID NCT00093353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of three oral drugs (irinotecan, temozolomide, and cefixime) in 30 children whose high-risk neuroblastoma had come back or not responded to standard treatment. The goal was to find the safest dose of irinotecan when given with the other two drugs. Cefixime was included to help prevent diarrhea, a common side effect of irinotecan. The study focused on side effects and dosing, not on curing 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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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May 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: * Histologically confirmed neuroblastoma AND/OR demonstration of tumor cells in the bone marrow with increased urinary catecholamines * High-risk disease meeting 1 of the following criteria: * Recurrent or progressive disease * Resistant or refractory disease (i.e., never achieved a complete response to therapy AND never had new sites of disease or progression of initial sites) * Measurable disease meeting at least 1 of the following criteria: * Unidimensionally measurable tumor ≥ 20 mm by MRI, CT scan, or x-ray OR ≥ 10 mm by spiral CT scan\* * At least 1 site with positive uptake by metaiodobenzylguanidine (MIBG) scan\* * Bone marrow with tumor cells seen on routine morphology (not by NSE staining only) of bilateral aspirate AND/OR biopsy on 1 bone marrow sample NOTE: \*Patients who never experienced disease recurrence or progression must demonstrate viable neuroblastoma in a biopsy of either bone marrow or bone and/or soft tissue site (biopsy must be performed ≥ 4 weeks after completion of prior radiotherapy if lesion was irradiated) PATIENT CHARACTERISTICS: Age * 1 to 30 at diagnosis Performance status * ECOG 0-2 Life expectancy * At least 2 months Hematopoietic * Absolute neutrophil count ≥ 750/mm\^3 * Platelet count ≥ 75,000/mm\^3 (without transfusion) * Hemoglobin ≥ 8.0 g/dL (transfusion allowed) Hepatic * SGPT and SGOT \< 5 times normal * Bilirubin ≤ 1.5 times normal Renal * Creatinine ≤ 1.5 times normal for age * No greater than 0.8 mg/dL (≤ 5 years of age) * No greater than 1.0 mg/dL (6 to 10 years of age) * No greater than 1.2 mg/dL (11 to 15 years of age) * No greater than 1.5 mg/dL (\> 15 years of age) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to cephalosporins * No active diarrhea * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * Recovered from prior immunotherapy * More than 3 weeks since prior biologic therapy and recovered * More than 2 days since prior hematopoietic growth factors * No concurrent epoetin alfa * No concurrent prophylactic hematopoietic growth factors during the first treatment course * No concurrent immunomodulating agents except steroids to control intracranial pressure Chemotherapy * Prior myeloablative therapy and autologous stem cell transplantation allowed * No prior allogeneic stem cell transplantation * More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * Prior temozolomide, irinotecan, or topotecan allowed * No prior temozolomide and irinotecan as combination therapy * No other concurrent chemotherapy Endocrine therapy * See Biologic therapy Radiotherapy * At least 6 weeks since prior large field radiotherapy (e.g., total body irradiation, craniospinal therapy, whole abdomen, total lung, or \> 50% bone marrow space) and recovered * At least 4 weeks since prior radiotherapy to biopsied lesions (for study entry) and recovered * At least 6 weeks since prior MIBG therapy * Concurrent radiotherapy to painful lesions allowed provided the lesions are not used to assess treatment response Surgery * Not specified Other * No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine) * No other concurrent anticancer agents
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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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AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, 30322, United States
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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 and Regional Medical Center - Seattle
Seattle, Washington, 98105, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
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Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
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Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, 94304, United States
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Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, 77030-2399, United States
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UCSF Comprehensive Cancer Center
San Francisco, California, 94143, United States
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0718, United States
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