drugset / Trial / NCT00392691

Melphalan, Yttrium Y 90 Ibritumomab Tiuxetan, and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

NCT00392691

Phase 1 Completed 20 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell transplant helps stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Also, monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Chemotherapy and monoclonal antibody therapy also prepares the patient's bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as G-CSF, and vinorelbine helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous stem cell transplant in treating older patients with non-Hodgkin's lymphoma that has relapsed or not responded to previous treatment.

Timeline

Start
2006-10
Primary completion
2012-12
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule 100 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous
Subject Melphalan Small molecule 170 mg/m2 Intravenous
Subject Melphalan Small molecule 200 mg/m2 Intravenous
Subject Vinorelbine Small molecule 35 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 250 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous
Background ibritumomab tiuxetan Monoclonal antibody 14.8 mbq/kg Intravenous

Indications