drugset / Trial / NCT00882206

Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic Leukemia

NCT00882206

Phase 2 Terminated 15 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine and vorinostat may alter the cancer cells by reversing the cancer pathways needed for cell growth. Giving more than one drug (combination chemotherapy) together with decitabine and vorinostat may kill more cancer cells than with chemotherapy alone. PURPOSE: This phase II trial is studying how well giving decitabine and vorinostat together with combination chemotherapy works in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma that has relapsed or not responded to treatment.

Timeline

Start
2009-04
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 15 mg/m2 Intravenous
Subject Vorinostat Small molecule 230 mg/m2 Oral
Background Cytarabine Small molecule 30 mg Intrathecal
Background Cytarabine Small molecule 70 mg Intrathecal
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Imatinib Small molecule 340 mg/m2 Oral
Background Imatinib Small molecule 400 mg Oral
Background Methotrexate Small molecule 8 mg Intrathecal
Background Methotrexate Small molecule 15 mg Intrathecal
Background Pegaspargase Protein / enzyme biologic 2500 iu Intramuscular
Background Prednisone Other / unclassified 40 mg/m2 Oral
Background Vincristine Small molecule 1.5 mg/m2 Intravenous

Indications