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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002663 |
RATIONALE: Some types of lymphoma or lymphoproliferative disease are associated with Epstein-Barr virus. White blood cells from donors who are immune to Epstein-Barr virus may be an effective treatment for those cancers.
PURPOSE: This phase I/II trial is studying the side effects and best dose of biological therapy in treating patients with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.
Condition | Intervention | Phase |
Leukemia Lymphoma |
Drug: allogeneic Epstein-Barr virus-specific cytotoxic T lymphocytes |
Phase I Phase II |
MedlinePlus related topics: | Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases |
Estimated Enrollment: | 18 |
Study Start Date: | March 1995 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose escalation study. Patients are stratified according to graft vs host disease risk (high vs low).
Patients receive adoptive immunotherapy with allogeneic Epstein Barr virus (EBV) specific cytotoxic T lymphocytes IV on days 1, 8, and 15. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
The dose of allogeneic EBV specific cytotoxic T lymphocytes is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed every 2 weeks for 6 months, every 2 months for 2 years, and then every 4 months until disease progression.
PROJECTED ACCRUAL: Approximately 3-18 patients per stratum will be accrued for this study within 1-2 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunocompromised as a consequence of:
Normal lymphocyte donor related to patient or, for organ allografts, to organ:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: Esperanza B. Papadopoulos, MD 212-639-8276 papadope@mskcc.org |
Memorial Sloan-Kettering Cancer Center |
Study Chair: | Richard J. O'Reilly, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000064247, MSKCC-95024, NCI-V95-0685 |
First Received: | November 1, 1999 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00002663 |
Health Authority: | Unspecified |
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