Combination of Vorinostat and Bortezomib in Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00810576
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Dose of 200 mg by mouth twice daily on days 1-14 of each 21-day study.
  • Bortezomib — DRUG
    Dose of 1.3 mg/m\^2 by vein on days 1, 4, 8, and 11 of a 21 day cycle.

Study Details

Primary Objectives: 1. To evaluate the response rate for patients with T-cell Non-Hodgkin's Lymphoma (NHL)receiving the combination of vorinostat and bortezomib 2. To evaluate the safety and tolerability of the combination of vorinostat and bortezomib in patients with relapsed or refractory T-cell NHL. Secondary Objectives: 1. To assess overall survival and time to treatment failure in patients with T-cell NHL treated with the combination of vorinostat and bortezomib. 2. Correlative studies will be done to assess the role of vorinostat mediated apoptosis along with bortezomib synergy. Changes in marker expression from baseline to post treatment will be correlated with patient clinical response.

Key Dates

Start date
Jan 31, 2009
Status verified
Aug 2012
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

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

Arms

  • Experimental: Vorinostat + Bortezomib
    Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m\^2 intravenous (IV) on Days 1, 4, 8, 11.

Primary Outcome Measure

Number of Patients With Response [ Time Frame: Every two 21-day cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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By research site
UT MD Anderson Cancer Center· Houston, TX

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