NCT00078546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2003

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

3.3 years

First QC Date

March 1, 2004

Last Update Submit

July 27, 2012

Conditions

Nasopharyngeal CancerEBV Infections

Keywords

EBVNASOPHARYNGEALCARCINOMAEBV POSITIVE NASOPHARYNGEAL CARCINOMA

Outcome Measures

Primary Outcomes (3)

  • safety of autologous Epstein Barr Virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (Mab) in patients with nasopharyngeal cancer

    6 weeks post infustion

  • obtain information on the expansion, persistence and anti-tumor effects of EBV-specific CTL lines given after lymphodepletion with CD45 Mab in patients with nasopharyngeal cancer

    12 months post infusion

  • 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.

    12 months post infusion

Interventions

EBV specific CTL InfusionBIOLOGICAL

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

Anti CD45 monoclonal antibodyBIOLOGICAL

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

Also known as: YTH 24/54

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with EBV positive NPC, in relapse or with primary resistant disease
  • Life expectancy of more than 6 weeks.
  • No severe intercurrent infection
  • Patient, parent/guardian able to give informed consent
  • Bilirubin less than 2x normal
  • SGOT less than 3x normal,
  • Hgb higher than 8.0 g/L
  • Creatinine less than 2x normal for age
  • Patients should have been off other investigational therapy for one month prior to entry in this study.
  • Karnofsky score of over or equal to 50.

You may not qualify if:

  • Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
  • Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Louis CU, Straathof K, Bollard CM, Gerken C, Huls MH, Gresik MV, Wu MF, Weiss HL, Gee AP, Brenner MK, Rooney CM, Heslop HE, Gottschalk S. Enhancing the in vivo expansion of adoptively transferred EBV-specific CTL with lymphodepleting CD45 monoclonal antibodies in NPC patients. Blood. 2009 Mar 12;113(11):2442-50. doi: 10.1182/blood-2008-05-157222. Epub 2008 Oct 29.

    PMID: 18971421DERIVED

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsEpstein-Barr Virus InfectionsCarcinoma

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Stephen Gottschalk, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics Hematology Oncology

Study Record Dates

First Submitted

March 1, 2004

First Posted

March 2, 2004

Study Start

September 1, 2003

Primary Completion

January 1, 2007

Study Completion

April 1, 2007

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(2)