Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT01686165
Phase
PHASE2
Status
Completed

Conditions

  • Anaplastic Large Cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • belinostat — DRUG
    Given IV
  • rituximab — BIOLOGICAL
    Given IV
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION
    Given IV

Study Details

This study looks at what effects (good and bad) a drug called PXD-101 (belinostat) in combination with the radioactive drug Zevalin (yttrium Y 90 ibritumomab tiuxetan) has on patients with relapsed aggressive (high-risk) non-Hodgkin lymphoma. Studies in the laboratory suggest that drugs such as PXD101 can act upon specific cancer cell processes to cause either death of the cancer cells or prevention of their growth. In human studies with a small number of patients with this lymphoma, PXD-101 has shown the ability to shrink and slow tumor growth. When Zevalin is delivered directly to the tumor, the lymphoma cells are destroyed and this may result in the disappearance of the tumor (remission)

Key Dates

Start date
Aug 31, 2012
Status verified
Jul 2018
Primary completion
Feb 9, 2016
Completion
Nov 9, 2017

Study Design

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

Arms

  • Experimental: Belinostat Yttrium Ibritumomab Tiuxetan
    Patients receive belinostat IV over 30-60 minutes on days 1-5. Treatment with belinostat repeats every 21 days for 2 courses. Patients then receive rituximab IV on days 1 and either 7, 8, or 9, and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 50. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete Response Rate [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-5024-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZ

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