Spots Global Cancer Trial Database for N99-02: Melphalan and Buthionine Sulfoximine

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Trial Identification

Brief Title: N99-02: Melphalan and Buthionine Sulfoximine

Official Title: Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) Autologous Stem Cell Support for Resistant or Recurrent High-Risk Neuroblastoma (IND 69-112)

Study ID: NCT00005835

Conditions

Neuroblastoma

Interventions

buthionine sulfoximine

melphalan

Peripheral blood stem cell infusion

Filgrastim

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine followed by bone marrow or peripheral stem cell transplantation in treating children who have resistant or recurrent neuroblastoma.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose of melphalan when combined with buthionine sulfoximine and followed by autologous bone marrow or peripheral blood stem cell support in children with resistant or recurrent high-risk neuroblastoma. * Assess the toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine the response rate of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of melphalan. Patients receive buthionine sulfoximine IV as a bolus over 30 minutes followed by a 72-hour continuous infusion beginning on day -4; melphalan IV over 15 minutes on days -3 and -2; autologous peripheral blood stem cells or bone marrow IV over 15-30 minutes on day 0; and filgrastim (G-CSF) subcutaneously or IV once daily beginning on day 0 and continuing until blood counts recover. Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 84 days and then 2 months later if there is a complete and/or partial response. Patients who continue therapy on other protocols are followed before starting the new therapy. All patients are followed for life for any delayed toxic effects to protocol therapy and secondary malignancies. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 years.