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

Stopped early · Phase 2

Conditions studied: Leukemia, Lymphoma

In brief

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 facts

Study ID

NCT00882206

Run by

Masonic Cancer Center, University of Minnesota

People needed

15

Starts

2009-04-01

Expected to finish

2013-01-01

Last updated by the study team

2017-12-28

Who can join

Age: 2 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of lymphoblastic lymphoma or acute lymphoblastic leukemia with ≥ 5% blasts in the bone marrow (M2/M3) (with or without extramedullary disease) that meets 1 of the following criteria:
• Refractory disease/induction failure (failure to achieve initial remission after 2 lines of induction therapy)
• Relapsed disease (in first relapse or higher)
• Central nervous system (CNS)-positive disease allowed
• Karnofsky performance status (PS) 50-100% (for patients ≥ 16 years of age) OR Lansky PS 50-100% (for patients < 16 years of age)
• Life expectancy ≥ 8 weeks
• Creatinine clearance ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
• 0.4 mg/dL (for patients 1 to 5 months of age)
• 0.5 mg/dL (for patients 6 to 11 months of age)
• 0.6 mg/dL (for patients 1 year of age)
• 0.8 mg/dL (for patients 2 to 5 years of age)
• 1.0 mg/dL (for patients 6 to 9 years of age)
• 1.2 mg/dL (for patients 10 to 12 years of age)
• 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
• 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
• ALT < 5 times upper limit of normal (ULN)
• Total bilirubin ≤ 1.5 times ULN for age
• LVEF ≥ 40% by ECHO/MUGA scan
• Shortening fraction > 29% by ECHO/MUGA scan
• Able to swallow capsules
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after completion of study treatment
• No untreated positive blood cultures or progressive infections as assessed by radiographic studies
• No known allergy to any of the agents or their ingredients used in this study

You may not qualify if…

• Evidence of graft-versus-host disease
• Concurrent valproic acid
• Concurrent coumadin/warfarin other than a short course administered in a prophylactic setting

Where it is running

• University of Minnesota Amplatz Children's Hospital — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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