Clinical trial NCT00882206
Conditions: Leukemia Lymphoma
Keywords: recurrent adult lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent adult acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2009-04-01; Completion date: 2013-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
Interventions: intervention 1: cytarabine intervention 2: decitabine intervention 3: doxorubicin hydrochloride intervention 4: imatinib mesylate intervention 5: methotrexate intervention 6: pegaspargase intervention 7: prednisone intervention 8: vincristine sulfate intervention 9: vorinostat
Intervention descriptions: intervention 1: At baseline when peripheral blood draw and bone marrow aspirate performed.

\*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg. intervention 2: Days 1-4, 15 mg/m\^2 intravenously (IV) over 1 hour intervention 3: Day 5, 60 mg/m\^2 intravenously (IV) over 15 minutes intervention 4: 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. intervention 5: \*\*Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg. intervention 6: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26) intervention 7: 40mg/m2/day divided BID (days 5 - 33) intervention 8: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12, 19, 26) intervention 9: Days 1-4, (230 mg/m2)orally divided twice a day (max dose 400 mg daily)

Protocol documents: