Bortezomib, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory Low-Grade, Follicular, or Mantle Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT00334438
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    250mg/m2, IV, Days 1 and 8
  • bortezomib — DRUG
    dose escalation 1.0, 1.3, or 1.5, IVP; Days 4, 8, 11, 15
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION
    Dose dependant upon platelet count (0.4mCi/kg) not to exceed 32mCi; Day 8
  • Indium 111 ibritumomab tiuxetan — RADIATION
    5cmCi; IV day 1

Study Details

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, and radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan in treating patients with relapsed or refractory low-grade, follicular, or mantle cell non-Hodgkin's lymphoma.

Key Dates

Start date
Jul 31, 2006
Status verified
Dec 2016
Primary completion
Oct 31, 2008
Completion
Oct 31, 2011

Study Design

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

Arms

  • Other: Zevalin + Velcade Single Arm Study
    Zevalin (Ibritumomab Tiuxetan) and Velcade (Bortezomib)

Primary Outcome Measure

Maximum tolerated dose of bortezomib [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Hackensack University Medical Center Cancer CenterHackensackNew Jersey07601-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-

Find similar trials in Hackensack, NJ

By research site
Hackensack University Medical Center Cancer Center· Hackensack, NJLineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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