Lymphoma Clinical Trial
Official title:
A Therapeutic Trial of Decitabine and Vorinostat in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
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.
OBJECTIVES:
Primary
- Patients undergo blood and bone marrow sample collection at baseline, on day 5, Day 19
and at the end of study treatment for correlative laboratory studies. Samples are
analyzed for hypermethylation at diagnosis and demethylation post-exposure with
decitabine and vorinostat using LINE methylation.
OUTLINE:
Patients receive decitabine IV over 1 hour and oral vorinostat twice daily on days 1-4;
vincristine sulfate IV on days 5, 12, 19, and 26; oral prednisone twice daily on days 5-33;
doxorubicin hydrochloride IV over 15 minutes and cytarabine intrathecally (IT) on day 5;
pegaspargase IV or intramuscularly on days 6, 12, 19, and 26; and methotrexate* IT on days 12
and 33. Patients with Philadelphia chromosome-positive disease may also receive oral imatinib
mesylate once daily on days 5-33.
NOTE: *Patients with central nervous system (CNS)-positive disease also receive methotrexate
IT on days 19 and 26.
Patients undergo blood and bone marrow sample collection at baseline, on day 5, Day 19 and at
the end of study treatment for correlative laboratory studies.
After completion of study treatment, patients are followed for 60 days.
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