MedTrace Logo

Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

NCT00004874 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-01-17

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase III trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Conditions

Interventions

RADIATION

tositumomab and iodine I 131 tositumomab

Dosimetric Dose:Unlabeled anti-B1 (450mg) will be given as peripheral or central IV infusion over one hour or longer depending upon rate-dependent side effects. A trace-labeled dose of 131I-anti-B will be infused over 20 minutes, if rate-dependent side effects permit. An amount of unlabeled Anti-B1 Antibody is added to the 5 mCi of Iodine-131 Anti-B1 Antibody sufficient to result in a final amount of 35 mg of Anti-B1 antibody. On study Day 7 (may be delayed up to study Day 14), patients will receive the therapeutic dose, which consists of an infusion of 450mg of Anti-B1 Antibody followed by an infusion of Iodine-131 Anti-B1 Antibody.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Coulter Pharmaceutical, Inc.

    collaborator INDUSTRY

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Julie M. Vose, MD · University of Nebraska

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-11-30
Primary Completion
2002-04-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004874 on ClinicalTrials.gov