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