A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab

NCT00001805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2008-03-04

No results posted yet for this study

Summary

This is a phase II clinical and pharmacokinetic study of suppression of human antimouse (HAMA) and antitoxin antibodies (HATA) to immunotoxin LMB-1 by Rituximab (anti-CD20). The primary objective of this study is to determine the effect of Rituximab on HAMA and HATA response to LMB-1 administered to patients with advanced carcinoma that express the B3 antigen. Other objectives include evaluation of the pharmacokinetics and anti-tumor effects.

Conditions

  • Breast Neoplasms
  • Colonic Neoplasms
  • Lung Neoplasms
  • Pancreatic Neoplasms
  • Stomach Neoplasms

Interventions

DRUG

Rituximab

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Completion
2000-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT00001805 on ClinicalTrials.gov