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

NCT00882206 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-12-28

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Michael J. Burke, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882206 on ClinicalTrials.gov