NCT00882206

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
DRUG	cytarabine	At baseline when peripheral blood draw and bone marrow aspirate performed. \*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.
DRUG	decitabine	Days 1-4, 15 mg/m\^2 intravenously (IV) over 1 hour
DRUG	doxorubicin hydrochloride	Day 5, 60 mg/m\^2 intravenously (IV) over 15 minutes
DRUG	imatinib mesylate	340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age \<18 years and 400 mg orally every day for \>18 years on Days 5-33.
DRUG	methotrexate	\*\*Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.
DRUG	pegaspargase	2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)
DRUG	prednisone	40mg/m2/day divided BID (days 5 - 33)
DRUG	vincristine sulfate	1.5mg/m2 (max 2 mg) iv push q week (days 5, 12, 19, 26)
DRUG	vorinostat	Days 1-4, (230 mg/m2)orally divided twice a day (max dose 400 mg daily)

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-04-16
• Last updated: 2017-12-28
• Results posted: 2016-10-28

Locations

1 site across 1 country: United States