Bortezomib and Vorinostat in Treating Patients With Recurrent Mantle Cell Lymphoma or Recurrent and/or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00703664
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Mantle Cell Lymphoma
  • Recurrent Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Bortezomib — DRUG
    Bortezomib: 1.3 mg/m\^2/d IV days 1, 4, 8, and 11.
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Vorinostat — DRUG
    Vorinostat: 400 mg (total daily dose as a single dose) days 1-5 and 8-12.

Study Details

This phase II trial studies how well bortezomib and vorinostat work in treating patients with recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jul 9, 2008
Status verified
Jul 2018
Primary completion
Dec 1, 2017
Completion
Dec 1, 2017

Study Design

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

Arms

  • Experimental: Treatment (vorinostat, bortezomib)
    Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. Treatment arm consists of 3 cohorts, all receiving the same treatment: A: Mantle Cell Lymphoma (MCL) - with no prior bortezomib. B: Mantle Cell Lymphoma (MCL) - with no prior bortezomib. C: Diffuse Large B-Cell Lymphoma (DLBCL) - with no prior bortezomib.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 9 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Weill Medical College of Cornell UniversityNew YorkNew York10065-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLEmory University Hospital/Winship Cancer Institute· Atlanta, GANorthwestern University· Chicago, ILUniversity of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Maryland/Greenebaum Cancer Center· Baltimore, MDRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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