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

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