SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00787527
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Zolinza (vorinostat) — DRUG
    Up to two 100 mg capsules of Vorinostat (dosage will vary from 100 mg orally (PO) twice daily (BID), 300 mg PO every evening and 200 mg PO BID with the starting dose at 300 mg PO every evening for the phase I trial) are to be administered orally twice daily (once in the morning and once in the evening, or if in the daily dosing cohort once in the evening) in repeated 21-day cycles consisting of 10 days dosing starting on days 5 through 14 followed by a 7-day rest period, during which no vorinostat will be administered.
  • Cyclophosphamide — DRUG
    750 mg/m\^2 by vein over 1 hour on Day 1 of 21 day cycle
  • Doxorubicin — DRUG
    50 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
  • Vincristine — DRUG
    1.4 mg/m\^2 by vein over 15 minutes on Day 1 of 21 day cycle
  • Prednisone — DRUG
    100 mg tablets by mouth once a day on Days 1-5 of 21 day cycle

Study Details

The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell Non-Hodgkin's Lymphoma (NHL). The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied.

Key Dates

Start date
Nov 30, 2008
Status verified
Sep 2014
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: Zolinza + CHOP
    Zolinza (vorinostat) + CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)

Primary Outcome Measure

Phase I Maximum Tolerated Dose (MTD) of Vorinostat [ Time Frame: 21 Days ]

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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