Brief Summary

Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not gone away or is at high risk for coming back after treatment (including the best treatment we know for nasopharyngeal cancer). We are asking patients to volunteer to be in a research study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new experimental therapy. Most patients with nasopharyngeal cancer show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer, suggesting that it may play a role in causing this cancer. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells (called T cells) that have been trained to kill EBV-infected cells can survive in the patient's blood and affect the tumor. We have treated other patients with different EBV positive cancers and have had variable results. Some patients have had some response to the treatment. Some patients have been cured by the treatment. It is not possible for us to predict if this treatment will work for nasopharyngeal cancer. The purposes of this study are to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are, and to see whether this therapy might help patients with nasopharyngeal cancer.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Timeline

Completed

Started Aug 2001

Longer than P75 for phase_1 head-and-neck-cancer

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

10.8 years study duration

Study Start

First participant enrolled

August 1, 2001

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed

4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed

Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

6.2 years

First QC Date

February 2, 2008

Last Update Submit

October 5, 2012

Conditions

Head and Neck Cancer

Keywords

recurrent nasopharyngeal cancerstage II nasopharyngeal cancerstage III nasopharyngeal cancerstage IV nasopharyngeal cancer

Outcome Measures

Primary Outcomes (1)

Safety of two IV injections of autologously derived Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTLs)
Patients will be enrolled at the first dose level and followed for six weeks after the second dose (which will constitute a course) for evaluation of any critical toxicity
6 weeks

Secondary Outcomes (1)

the survival, immunological efficacy and anti-tumor effects of EBV specific cytotoxic T-lymphocyte lines.
12 months

Study Arms (1)

EBV specific CTL

EXPERIMENTAL

autologous EBV specific CTLs

Biological: autologous EBV specific CTLs

Interventions

autologous EBV specific CTLsBIOLOGICAL

30-40cc of peripheral blood will be used to generate EBV specific CTLs Group One: Day 0 - 2 x 10\^7 cells/m2 Day 14 - 2 x 10\^7 cells/m2 Group Two: Day 0 - 2 x 10\^7 cells/m2 Day 14 - 1 x 10\^8 cells/m2 Group Three: Day 0 - 1 x 10\^8 cells/m2 Day 14 - 2 x 10\^8 cells/m2

Also known as: EBV specific CTLs

EBV specific CTL

Eligibility Criteria

Sexall

Healthy VolunteersNo

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

You may qualify if:

All patients with NPC in first or subsequent relapse or with primary refractory disease or high risk (T3 or T4, or node positive disease) in whom the EBV genome or antigens have been demonstrated in tissue biopsies will be eligible for this trial. -Patients with a life expectancy \>6 weeks
Patients with a Karnofsky score of \>/= 50
No severe intercurrent infection.
Patient, parent/guardian able to give informed consent.
Patients with bilirubin \<2x normal, SGOT \<3x normal, and Hgb \>8.0
Patients with a creatinine \<2x normal for age
Patients should have been off other investigational therapy for one month prior to entry in this study.

You may not qualify if:

Patients with a life expectancy of \<6 weeks. -Patients with a Karnofsky score of \< 50. -Patients with a severe intercurrent infection. -Patient, parent/guardian unable to give informed consent. -Patients with a bilirubin \>2x normal. SGOT \>3x normal or abnormal prothrombin time. -Patients with a creatinine \>2x normal for age -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 investigators discretion after approval by the CAGT Protocol Review Committee and the FDA reviewer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Baylor College of Medicinelead
The Methodist Hospital Research Institutecollaborator
Center for Cell and Gene Therapy, Baylor College of Medicinecollaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

Louis CU, Straathof K, Bollard CM, Ennamuri S, Gerken C, Lopez TT, Huls MH, Sheehan A, Wu MF, Liu H, Gee A, Brenner MK, Rooney CM, Heslop HE, Gottschalk S. Adoptive transfer of EBV-specific T cells results in sustained clinical responses in patients with locoregional nasopharyngeal carcinoma. J Immunother. 2010 Nov-Dec;33(9):983-90. doi: 10.1097/CJI.0b013e3181f3cbf4.
PMID: 20948438BACKGROUND
Straathof KC, Bollard CM, Popat U, Huls MH, Lopez T, Morriss MC, Gresik MV, Gee AP, Russell HV, Brenner MK, Rooney CM, Heslop HE. Treatment of nasopharyngeal carcinoma with Epstein-Barr virus--specific T lymphocytes. Blood. 2005 Mar 1;105(5):1898-904. doi: 10.1182/blood-2004-07-2975. Epub 2004 Nov 12.
PMID: 15542583RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsNasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

Helen E. Heslop, 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: Professor, Director-Adult Stem Cell Transplant Program

Study Record Dates

First Submitted

February 2, 2008

First Posted

February 6, 2008

Study Start

August 1, 2001

Primary Completion

October 1, 2007

Study Completion

June 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

US(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

EBV specific CTL

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations