Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Eastern Cooperative Oncology Group
With
OBJECTIVES: * Determine the maximum tolerated dose (MTD) of high-dose melphalan administered with amifostine in patients with primary systemic amyloidosis undergoing autologous peripheral blood stem cell transplantation. * Determine the toxicity of high-dose melphalan when administered at the MTD in these patients. * Determine the response rate in patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter, dose-escalation study of melphalan. Patients receive filgrastim (G-CSF) subcutaneously once daily until peripheral blood stem cell (PBSC) collection is complete. Apheresis begins on day 5 of G-CSF administration and continues until the target number of PBSCs are collected. Within 6 weeks of PBSC collection, patients receive amifostine IV over 5 minutes on days -2 and -1 and high-dose melphalan IV over 30-60 minutes on day -1. Patients undergo autologous PBSC infusion on day 0. 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose. Patients are followed approximately 3 months following transplantation, then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 3-46 patients will be accrued for this study within 2.3 years.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
