drugset / Trial / NCT00609739

Cytosine Arabinoside and Mitoxantrone for Patients With Juvenile Myelomonocytic Leukemia Receiving Repeat Stem Cell Transplantation

NCT00609739

Phase 1/2 Terminated 1 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy drugs, such as cytarabine and mitoxantrone, before a donor stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, and methylprednisolone before or after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects and best way to give high-dose cytarabine together with mitoxantrone in treating patients with juvenile myelomonocytic leukemia undergoing a second donor stem cell transplant.

Timeline

Start
1999-06
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 3000 mg/m2 Intravenous
Subject Mitoxantrone Small molecule 10 mg/m2 Intravenous
Background Cyclosporine Peptide 2.5 mg/kg Intravenous
Background Isotretinoin Other / unclassified 100 mg/m2 Oral
Background Methotrexate Small molecule 10 mg/m2 Intravenous
Background Methylprednisolone Other / unclassified 1 mg/kg Intravenous
Background filgrastim Protein / enzyme biologic 5 ug/kg

Indications