Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT00691210
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
  • Niacinamide — DRUG
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
  • Etoposide — DRUG
    Dose escalation scheme (0, 25, 50, 100 mg/m2) Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."

Study Details

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. The investigators want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.

Key Dates

Start date
Jun 30, 2008
Status verified
Nov 2020
Primary completion
Feb 28, 2014
Completion
Mar 31, 2015

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: V/N: Level 1
    Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg
  • Experimental: V/N: Level 2
    Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg
  • Experimental: V/N: Level 3
    Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg
  • Experimental: V/N: Level 4
    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg
  • Experimental: V/N: Level 5
    Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg
  • Experimental: V/N/E: Level 1
    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2
  • Experimental: V/N/E: Level 2
    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2
  • Experimental: V/N/E: Level 3
    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2

Primary Outcome Measure

The Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Lymphoid Malignancies at CUMCNew YorkNew York10019-

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Center for Lymphoid Malignancies at CUMC· New York, NY

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