N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma

You may be eligible if

• 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