drugset / Trial / NCT00058292

Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT00058292

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Timeline

Start
2000-04
Primary completion
2006-06
Completion
2009-03

Publications

  • Results Winter J, Inwards D, Spies S, et al.: Zevalin® (90YZ) doses >.5 mCi/kg may be combined with high-dose beam and autotransplant (ASCT). [Abstract] Ann Oncol 16 (Suppl 5): A-215, v100, 2005.

Drugs

EvaluationDrugModalityDoseRoute
Background Cytarabine Small molecule 100 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Melphalan Small molecule 140 mg/m2 Intravenous
Background Rituximab Monoclonal antibody 250 mg/m2 Intravenous
Background carmustine Small molecule 300 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications