None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Queensland Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Stage III or IV nasopharyngeal carcinoma as defined by the 6th edition of the UICC TNM staging. 2. Geographically accessible for follow up 3.Informed consent (from patient, or patient and parent/guardian if aged < 16 years) 4.ECOG performance status 1, 2 or 3 (see Appendix G). 5.Life expectancy of at least three months.
Exclusion criteria
Exclusion criteria:1.EBV negative tumour, as found in project P4902.Inability to identify a LMP peptide to stimulate CTL cultures3.Positive serology for HIV, 4.Serology indicating active HBV infection or carrier status for HBV 5.Serology indicating active HCV infection6.Significant non –malignant disease 7.Psychiatric, addictive or any condition which may compromise the ability to participate in this trial8.Prior cancers, except those diagnosed > five years ago with no evidence of disease recurrence and clinical expectation of recurrence <5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix.9.Currently receiving immunosuppressive therapy, including corticosteroids.10.Pregnancy, or unwilling to use adequate contraception.
Outcome results
None listed