Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT00818649
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bortezomib — DRUG
    1.3mg/m\^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle
  • vorinostat — DRUG
    400 mg orally (po) every day on days 1-14 of a 21 day cycle

Study Details

RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous leukemia.

Key Dates

Start date
Jan 31, 2009
Status verified
Dec 2017
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

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

Arms

  • Experimental: Velcade + Vorinostat
    This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.

Primary Outcome Measure

Number of Patients by Best Clinical Response [ Time Frame: At Completion of Course 3 (Day 63) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-

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