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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT00882206
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2009
Status verified
Dec 2017
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Decitabine / Vorinostat
    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.

Primary Outcome Measure

Response to Treatment [ Time Frame: Day 33 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota Amplatz Children's HospitalMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Minnesota Amplatz Children's Hospital· Minneapolis, MN

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