CompletedPhase 1ACTRN12607000191493

Phase I Trial of Adoptive Immunotherapy for Stage III and IV Nasopharyngeal Carcinoma

Phase I trial to assess the safety of adoptive transfer of cytotoxic T cells specific for Epstein Barr Virus (EBV) latent membrane proteins (LMP) in patients with Stage III and IV nasopharyngeal carcinoma


Sponsor

Queensland Institute of Medical Research

Enrollment

10 participants

Start Date

Mar 5, 2007

Study Type

Interventional

Conditions

Summary

Phase I This is a trial of adoptive immunotherapy as treatment for nasopharyngeal carcinoma, stage 2, 3 and 4. Who is it for? You can join this study if you have cancer of the nasopharynx (an area in the back of the nose toward the base of skull) (NPC), stage 2, 3 and 4. Trial details Blood cells are taken from participants who's tumour tissue is Epstein-Barr Virus (EBV) positive. T-cells are isolated from the blood and cytotoxic T-lymphocytes (CTL's) are grown in the laboratory, in the presence of an EBV latent membrane protein and used for ‘adoptive immunotherapy’ – a treatment used for cancer in which an individual's own white blood cells are coupled with a naturally produced growth factor to enhance their cancer-fighting capacity. Some 20–200 million cytotoxic T lymphocytes will be injected into the patient at 2 week intervals (minimum of three and up to six infusions). The study aims to look at the tolerability and safety of treatment, changes in blood immune results measured at intervals, and tumour response. Radiotherapy and chemotherapy are standard palliative treatments for people with advanced NPC. This trial assesses the safety and toxicity of adoptive immunotherapy in people with EBV positive tumours.


Eligibility

Sex: Both males and femalesMin Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase I trial tests adoptive immunotherapy (using specially prepared immune cells) for advanced nasopharyngeal carcinoma (NPC). This study is open to both men and women aged 15 and older. Participation involves receiving infusions of immune cells and regular follow-up to monitor your response and any side effects.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: Autologous latent membrane protein (LMP)-specific cytotoxic T lymphocytes (CTL) suspended in Albumex 4 and 10% Dimethyl Sulfoxide (DMSO). Between 20-200 x 106 LMP-CTL. Dose variation wit

Intervention: Autologous latent membrane protein (LMP)-specific cytotoxic T lymphocytes (CTL) suspended in Albumex 4 and 10% Dimethyl Sulfoxide (DMSO). Between 20-200 x 106 LMP-CTL. Dose variation within this range will depend on the manufacture/availability of cytotoxic T cells specific for Epstein Barr Virus (EBV) latent membrane proteins (LMP) 1 1nd 2. CTL will be transferred intravenously, total volume no greater than 14 mls. Duration of intervention: Autologous LMP-CTL will be transferred fortnightly, minimum of 3 and up to a total of 6 infusions will be performed. The number of infusions given to a trial subject (minimum of 3 and maximum of 6) will depend on the avilability of autologous LMP-CTL. The number of infusions will not increase if there were no changes within the immunological parameters. Trial treatment aims for 6 doses, but subjects, who complete 3 or more doses will be included in statistical analysis. Each infusion takes 30 to 45 minutes to administer. There is approximately two week interval between infusions.


Locations(1)

QLD, Australia

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ACTRN12607000191493


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