N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Res… (NCT00093353) | Clinical Trial Compass
CompletedPhase 1
N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
United States30 participantsStarted 2004-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Temozolomide may help irinotecan kill more tumor cells by making them more sensitive to the drug. Cefixime may be effective in preventing diarrhea that is caused by treatment with irinotecan.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with temozolomide and cefixime in treating young patients with recurrent or resistant neuroblastoma.
Who can participate
Age range1 Year – 30 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Trial details
NCT IDNCT00093353
SponsorNew Approaches to Neuroblastoma Therapy Consortium