Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00656617
Phase
PHASE2
Status
Completed

Conditions

  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Sex
ALL
Age
15 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Idarubicin — DRUG
    12 mg/m\^2 IV over 1 hour daily for 3 days (days 4 to 6)
  • Cytarabine — DRUG
    1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7)
  • Vorinostat — DRUG
    Initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).

Study Details

The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS. Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.

Key Dates

Start date
Apr 30, 2008
Status verified
Feb 2015
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: Idarubicin + Ara-C + Vorinostat
    Idarubicin 12 mg/m\^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m\^2 IV as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).

Primary Outcome Measure

Progression Free Survival (PFS) at 7 Months [ Time Frame: PFS Evaluation at 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

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