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| ID | Type | Description | Link |
|---|---|---|---|
| SINGAPORE-07-27-NPC |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's T lymphocytes that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and carboplatin together with laboratory-treated T lymphocytes works in treating patients with metastatic or locally recurrent Epstein-Barr virus-positive nasopharyngeal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo collection of peripheral blood mononuclear cells (PBMC) from which T cells are purified, co-cultured with irradiated autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTLs), and expanded in vitro for the establishment of cytotoxic T-cell lines.
Patients undergo blood sample collection at baseline and prior to each course of induction immunotherapy and maintenance immunotherapy. Samples are analyzed for EBV CTL frequency by immune function assays (i.e., tetramer analysis, enzyme-linked immunospot, and cytotoxic T-lymphocyte precursor assays); for specificity of response by cytotoxicity assays (in patients for whom the appropriate reagents are available); and for evaluation of EBV DNA by polymerase chain reaction. In addition, T-cells are isolated from blood samples for fluorescence-activated cell sorter analysis and for extraction of RNA.
After completion of study therapy, patients are followed at least every 2 months until disease progression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous Epstein-Barr virus-specific cytotoxic T lymphocytes | Biological | |||
| carboplatin | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| polymerase chain reaction | Genetic | |||
| fluorescence activated cell sorting | Other | |||
| immunoenzyme technique | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Median progression-free survival (PFS 1), defined as the time from study enrollment to the time of radiological disease progression or death from any cause |
| Measure | Description | Time Frame |
|---|---|---|
| Median PFS 2, defined as the time from the start of induction immunotherapy to radiological disease progression or death from any cause | ||
| Response rate, defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) after 4 courses of chemotherapy and the proportion of patients who achieve a further response after immunotherapy |
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DISEASE CHARACTERISTICS:
Biopsy-proven nasopharyngeal carcinoma (NPC)
Epstein-Barr virus (EBV)-positive disease as confirmed by in situ hybridization assay or PCR amplification for EBV-encoded RNA expression
Radiologically measurable disease
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy > 3 months
ANC > 1,200/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 8 g/dL
Bilirubin < 2 times upper limit of normal (ULN)
AST and ALT < 3 times ULN
Creatinine clearance ≥ 40 mL/min
Corrected calcium normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No concurrent severe illness, including any of the following:
No concurrent severe infections
HIV negative
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Toh Han Chong, MD, MBBS, MRCP | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre - Singapore | Recruiting | Singapore | 169610 | Singapore |
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| Clinical benefit rate of immunotherapy, defined as the proportion of patients who achieve CR, PR, or stable disease |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D016133 | Polymerase Chain Reaction |
| D005434 | Flow Cytometry |
| D007124 | Immunoenzyme Techniques |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
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