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Sponsored by: |
National Cancer Centre, Singapore |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00690872 |
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.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes Drug: carboplatin Drug: gemcitabine hydrochloride Procedure: fluorescence activated cell sorting Procedure: immunoenzyme technique Procedure: polymerase chain reaction |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Phase II Trial Evaluating Efficacy of a Strategy Employing Combination Gemcitabine and Carboplatin Chemotherapy Followed by EBV-Specific Cytotoxic T-Lymphocytes in Patients With Metastatic or Locally Recurrent EBV-Positive Nasopharyngeal Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | July 2008 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven nasopharyngeal carcinoma (NPC)
PATIENT CHARACTERISTICS:
No concurrent severe illness, including any of the following:
PRIOR CONCURRENT THERAPY:
Singapore | |
National Cancer Centre - Singapore | Recruiting |
Singapore, Singapore, 169610 | |
Contact: Toh Han Chong, MD 65-6436-8172 |
Principal Investigator: | Toh Han Chong, MD | National Cancer Centre, Singapore |
Study ID Numbers: | CDR0000577971, SINGAPORE-07-27-NPC |
Study First Received: | June 4, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00690872 |
Health Authority: | Unspecified |
recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Squamous cell carcinoma Pharyngeal Neoplasms Carboplatin Pharyngeal Diseases Recurrence Nasopharyngeal Neoplasms Carcinoma |
Epidermoid carcinoma Virus Diseases Nasopharyngeal carcinoma Head and Neck Neoplasms Carcinoma, squamous cell Stomatognathic Diseases Gemcitabine Carcinoma, Squamous Cell |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Nasopharyngeal Diseases |