T Lymphocytes in Patients With Severe Chronic Epstein-Barr Virus Infection - Full Text View

Purpose

RATIONALE: T lymphocytes that are treated in the laboratory may be effective in treating severe chronic Epstein-Barr virus infection.

PURPOSE: This phase I trial is studying the side effects and best dose of T lymphocytes in patients with severe chronic Epstein-Barr virus infection.

Condition	Intervention	Phase
Precancerous/Nonmalignant Condition	Drug: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled

Official Title:	AUTOLOGOUS EBV SPECIFIC CTLS FOR THERAPY OF SEVERE CHRONIC EBV INFECTION (SCAEBV)

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

Primary Outcome Measures:

Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Antiviral and immunological efficacy [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	August 2001
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To determine the safety of intravenous injections of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-cell lymphocytes (CTL) in patients with severe chronic EBV infection.
To determine antiviral and immunological efficacy of intravenous injections of CTLs in these patients.
To assess the clinical effects of these injections.

OUTLINE: Patients receive escalating doses of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-cell lymphocytes (CTL) IV in the absence of disease progression or unacceptable toxicity. Patients who achieve clinical response to the first infusion may receive up to 3 additional EBV-specific CTL infusions once every 3 months.

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Patients must have severe chronic Epstein-Barr virus (EBV) infection as manifested by 6 months of symptoms and one of the following:
- Elevated peripheral blood EBV DNA (> 4,000 genomes per μg peripheral blood mononuclear cell DNA)
- Free EBV DNA in serum or cerebrospinal fluid
- Vasoconstrictor assay antibody titer > 1/640
Cytotoxic T-cell lines are available

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Life expectancy ≥ 6 weeks
Creatinine < 3 times normal
Bilirubin < 5 times normal
Electrolytes, calcium, phosphorus, and nutritional status normal
Not pregnant or nursing
Fertile patients must use effective contraception
HIV-negative
No severe intercurrent infection

PRIOR CONCURRENT THERAPY:

More than 4 weeks since prior investigational agents
More than 1 week since prior high-dose steroids or other immunosuppressive drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608608

Sponsors and Collaborators

Baylor College of Medicine

Investigators


Study Chair:	Helen E. Heslop, 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:	CDR0000582410, BCM-H-8216, BCM-SCAEBV
First Received:	February 2, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00608608
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

Epstein-Barr virus infection

Study placed in the following topic categories:

Virus Diseases

Precancerous Conditions

DNA Virus Infections

Epstein-Barr Virus Infections

Herpesviridae Infections

Additional relevant MeSH terms:

Neoplasms

Tumor Virus Infections

Infection

Neoplasms, Experimental

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00608608