T Lymphocytes and Anti-CD45 Monoclonal Antibody in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00608257

Purpose

RATIONALE: White blood cells that are treated in the laboratory with Epstein-Barr virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as anti-CD45 monoclonal antibody, may stimulate the immune system in different ways and help to stop tumor cells from growing. Giving T lymphocytes treated in the laboratory together with anti-CD45 monoclonal antibody may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of T lymphocytes given after anti-CD45 monoclonal antibody in treating patients with Epstein-Barr virus-positive nasopharyngeal cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: anti-CD45 monoclonal antibody Drug: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes	Phase I

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Administration of EBV-Specific Cytotoxic T Lymphocytes Following CD45 Antibody to Patients With EBV Positive Nasopharyngeal Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in combination with anti-CD45 monoclonal antibody [ Designated as safety issue: Yes ]
Safety [ Designated as safety issue: Yes ]
Changes in laboratory data at baseline, 2, 4, 6, and 8 weeks and at 3 months [ Designated as safety issue: No ]
Extent and duration of immune depletion at pre-antibody infusion, pre-CTL infusion, 4 hours after infusion on days 3 and 4, and at 1, 2, 4, 6, and 8 weeks post-CTL infusion [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunologic function as measured by interferon-gamma, percentage of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma [ Designated as safety issue: No ]
Frequency of T-cells specific for CMV antigens (or for adenovirus in CMV-seronegative individuals) and EBV antigens at each time point of follow-up [ Designated as safety issue: No ]
Correlation between endogenously reconstituted versus adoptively transferred T-cells [ Designated as safety issue: No ]
Overall response rate [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	September 2003
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the safety of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in combination with anti-CD45 monoclonal antibody (Mab) in patients with nasopharyngeal cancer.
To obtain information on the expression, persistence, and anti-tumor effects of EBV-specific CTL lines given after lymphodepletion with anti-CD45 Mab in these patients.
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.

OUTLINE: This is a dose-escalation study of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL).

Patients undergo peripheral blood collection for the generation of EBV-specific CTL. Patients receive anti-CD45 monoclonal antibody (Mab) IV over 6-8 hours on days 1-4. Approximately 2-4 days later (when the anti-CD45 Mab level is < 100 μg/mL), patients receive 1 dose (dose is escalated in different patient cohorts) of EBV-specific CTL IV over 1-10 minutes. Patients achieving stable disease or partial response at 8-weeks or subsequent evaluations are eligible to receive up to 6 additional doses of EBV-specific CTL at 6-12 week interval.

Patients undergo blood sample collection periodically for immune function studies and plasma free CD45 antibody levels.

After completion of study treatment, patients are followed every 2 weeks for 8 weeks and then at 3, 6, 9, and 12 months.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of nasopharyngeal carcinoma meeting any 1 of the following criteria:
- First or subsequent relapse disease
- Primary refractory disease
- High-risk disease (T3 or T4, or node-positive disease)
EBV genome or antigens demonstrated in tissue biopsies (EBV-positive)

PATIENT CHARACTERISTICS:

Karnofsky performance status ≥ 50%
Life expectancy > 6 weeks
Hemoglobin > 8.0 g/dL
Bilirubin < 2 times normal
SGOT < 3 times normal
Creatinine < 2 times normal for age
Not pregnant
Fertile patients must use effective contraception (male partner should use a condom)
No severe intercurrent infection

PRIOR CONCURRENT THERAPY:

At least 1 month since prior investigational therapy
No other anti-neoplastic agents for ≥ 1 month post-CTL infusion
- Patients may receive other therapy if needed at the discretion of the attending physician

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608257

Locations

United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
Houston, Texas, United States, 77030-2399

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Study Chair:

Stephen Gottschalk, MD

Baylor College of Medicine

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000582383, BCM-H-14214, BCM-CLANC
Study First Received:	February 1, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00608257
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

recurrent nasopharyngeal cancer
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
stage II nasopharyngeal cancer

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Recurrence
Nasopharyngeal Neoplasms
Carcinoma

Virus Diseases
Antibodies, Monoclonal
Antibodies
Nasopharyngeal carcinoma
Head and Neck Neoplasms
Stomatognathic Diseases
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors

Physiological Effects of Drugs
Nasopharyngeal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009