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EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)

NCT00078546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-07-30

No results posted yet for this study

Summary

To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer.

To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given after CD45 Mab administration with that observed in our first study.

To obtain preliminary information on the safety and response to an extended dosage regimen of EBV-specific CTL in patients, who have stable disease or a partial response after the initial dose of EBV-specific CTL.

Conditions

  • Nasopharyngeal Cancer
  • EBV Infections

Interventions

BIOLOGICAL

EBV specific CTL Infusion

One injection at one of the following dose levels Dose level I: 2x107/m2 Dose level II: 5x107/m2 Dose level III: 1x108/m2

BIOLOGICAL

Anti CD45 monoclonal antibody

400ug/kg over 6 to 8 hr for 4 days

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Stephen Gottschalk, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-01-31
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00078546 on ClinicalTrials.gov