New York, New York 10065


Purpose:

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 at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.


Study summary:

OBJECTIVES: - Determine the toxicity and therapeutic potential of adoptive immunotherapy with Epstein Barr virus (EBV)-specific cytotoxic T lymphocytes derived from HLA-histocompatible related donors or haplotype-matched donor in the treatment of patients at high-risk or with EBV-induced lymphomas and other lymphoproliferative diseases or malignancies in immunocompromised hosts. - Complete a single selected dose level phase II extension of this study to identify the probability of achieving a CR of EBV lymphoma with EBV-specific T-cell therapy in allogeneic HSCT recipients and immunodeficient patients. - Evaluate in vivo biodistribution, expansion, and duration of engraftment of successive doses of EBV-reactive lymphocytes within immunocompromised histocompatible hosts with EBV-associated lymphoproliferative diseases, and correlate these findings with the patients' T-cell populations, general immune status, and capacity to generate allospecific antidonor response. - Determine incidence, kinetics, and durability of pathologic and/or clinical responses in this patient population treatment with infusions of these EBV-specific T cells. 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. After completion of study treatment, patients are followed periodically for 1 year.


Criteria:

DISEASE CHARACTERISTICS: - Pathologically documented Epstein-Barr virus (EBV) antigen-positive at risk or with lymphoproliferative disease, lymphoma, or other EBV-associated malignancy - Immunocompromised as a consequence of: - Genetic or acquired immunodeficiency (including AIDS) - Allogeneic bone marrow or organ transplant - Normal lymphocyte donor related to patient or, for organ allografts, to organ*: - Immunocompetent - HLA compatible - EBV seropositive - HIV negative - Organ donors at least HLA haplotype-identical with the lymphoma NOTE: *However, if the HSCT donor is EBV seronegative or not available (e.g., a cord blood transplant), EBV-specific T-cells generated from a normal seropositive related or unrelated donor matched for at least 2 HLA alleles may be used. - Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and Non-Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma. Normal, EBV specific T-cells from third party seropositive donors who are HLA compatible in at least 2 HLA alleles shared by the patient will be used. Selection of T cells known to be restricted by an HLA allele shared by the patient will be given priority. PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - No moribund patients Life expectancy: - At least 9 weeks Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Pregnant women eligible PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified


NCT ID:

NCT00002663


Primary Contact:

Principal Investigator
Susan Prockop, MD
Memorial Sloan Kettering Cancer Center

Susan Prockop, MD
Phone: 212-639-6715


Backup Contact:

Esperanza Papadopoulos, MD
Phone: 212-639-8276


Location Contact:

New York, New York 10065
United States

Susan J. Prockop, MD
Phone: 212-639-6715

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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