Decitabine, Vorinostat, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Part of paid clinical trials in Columbus, Ohio.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01130506
Phase
PHASE1
Status
Completed

Conditions

  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia
  • Secondary Acute Myeloid Leukemia
  • Therapy-Related Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    Given IV
  • Decitabine — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Vorinostat — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and the best dose of cytarabine when given together with decitabine and vorinostat in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has returned or has not responded to treatment. Drugs used in chemotherapy, such as cytarabine and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cytarabine together with decitabine and vorinostat may kill more cancer cells.

Key Dates

Start date
May 17, 2010
Status verified
Jul 2017
Primary completion
Nov 19, 2012

Study Design

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

Arms

  • Experimental: Treatment (decitabine, vorinostat, cytarabine)
    INDUCTION THERAPY: Patients receive decitabine IV over 1 hour on days 1-10; vorinostat PO on days 5-10; and high-dose cytarabine IV over 2 hours on days 12, 14, and 16 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR proceed to maintenance therapy. Patients who achieve CR with incomplete blood count recovery undergo bone marrow aspiration and biopsy at count recovery or day 42 before proceeding to maintenance therapy. MAINTENANCE THERAPY: Patients receive decitabine IV over 1 hour on days 1-5 and vorinostat PO on days 5-10. Treatment repeats every 28 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Correlative biologic studies [ Time Frame: Baseline up to 30 days past last dose of study drug ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OHM D Anderson Cancer Center· Houston, TX

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