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

Tracking Information

First Received Date ^ICMJE

February 2, 2008

Last Updated Date

February 6, 2009

Start Date ^ICMJE

August 2001

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum tolerated dose [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00608608 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled

Condition ^ICMJE

Precancerous/Nonmalignant Condition

Intervention ^ICMJE

Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00608608

Responsible Party

Study ID Numbers ^ICMJE

CDR0000582410, BCM-H-8216, BCM-SCAEBV

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Helen E. Heslop, MD

Baylor College of Medicine

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP