Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT00005592
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 90-Y-ibritumomab tiuxetan — BIOLOGICAL
    IDEC-Y2B8 is a mouse monoclonal antibody with small particles of radioactivity that join to the CD20 antigens on lymphoma cells. It is used to deliver radiation therapy to kill lymphoma cells. This is a one time intravenous infusion for eligible patients and is given over a ten-minute time period.
  • rituximab — BIOLOGICAL
    Rituxan is a mouse/human monoclonal antibody and reacts with the CD20 antigens found on lymphoma cells and causes the body's immune system to destroy the lymphoma cells. It is infused at a dose of 250 mg/m2 followed by a second infusion approximately one week later of the same dose.
  • indium In 111 ibritumomab tiuxetan — RADIATION
    IDEC-In2B8 is a mouse monoclonal antibody that contains Indium, routinely used in nuclear medicine. It is given as a one-time intravenous injection over a ten-minute time period immediately following a Rituxan infusion. The physician will then be able to see and evaluate the location and concentration of the antibody in the body.

Study Details

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Key Dates

Start date
Nov 30, 1999
Status verified
Oct 2015
Primary completion
Mar 31, 2002
Completion
Nov 30, 2005

Study Design

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

Arms

  • Experimental: Rituxan + IDEC-In2B8, Rituxan + IDEC-Y2B8
    For the first treatment, 250 mg/m2 Rituxan infusion and injection of IDEC-In2B8 (Indium- radioactive label) is given. If therapy is continued, approximately 1 week later a second infusion of Rituximab (250 mg/m2) is given followed by an infusion of IDEC-Y2B8 (Yttrium-radioactive label).

Primary Outcome Measure

To provide treatment to those patients with low-grade follicular or transformed B-cell non-Hodgkin's lymphoma who are not eligible for other IDEC-Y2B8 protocols. [ Time Frame: up to 4.25 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Comprehensive Cancer CenterBirminghamAlabama35294-3300-
Lombardi Cancer CenterWashington D.C.District of Columbia20007-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Comprehensive Cancer Center· Birmingham, ALLombardi Cancer Center· Washington D.C., DC

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