N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
Diarrhea, Drug/Agent Toxicity by Tissue/Organ, Neuroblastoma
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring diarrhea, drug/agent toxicity by tissue/organ, disseminated neuroblastoma, recurrent neuroblastoma
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Los Angeles
- Lucile Packard Children's Hospital at Stanford University Medical Center
- UCSF Comprehensive Cancer Center
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
- Children's Memorial Hospital - Chicago
- Indiana University Cancer Center
- Children's Hospital Boston
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
- Children's Hospital and Regional Medical Center - Seattle