None listed
Conditions
Brief summary
This study is assessing the efficacy, safety and tolerability of using T cell therapy targeting human cytomegalovirus (HCMV) in treating brain cancer (glioblastoma multiforme ). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with glioblastoma multiforme , and have not yet begun standard treatment for this disease . Trial details: Patients will be eligible if they have been recently diagnosed with glioblastoma multiforme and are about to begin standard radiotherapy and chemotherapy regimens. A blood sample will be taken from patients prior to beginning standard radiotherapy and chemotherapy, in order to grow the cells for the experimental therapy. These cells, known as T cells (a type of white blood cell) will be grown in the laboratory from each patient’s blood sample. After completing standard radiotherapy and chemotherapy regimens, all participants in this study will receive treatment with killer T cells (a type of white blood cell) which have been grown in the laboratory from the participant’s own white blood cells. Treatment consists of up to 6 infusions of T cells (given fortnightly or monthly, depending on the standard treatment regimen), and patients are monitored for 12 months afterwards to see if treatment is safe and to measure any reduction in tumour and amount of virus in the blood. Recent studies suggest that most gliomas carry a common virus, called human cytomegalovirus (HCMV), which is normally controlled by killer T cells. The study aims to see if killer T cells grown in the laboratory and trained to recognise components of the virus can also kill HCMV infected gliomas. The standard first-line treatment is usually surgery, radiotherapy and a chemotherapy drug called temozolomide. If the cancer then grows back, there are no known effective treatments.
Interventions
There will be a single treatment arm. Patients will be given up to six infusions every two to six weeks of 2x10e7 cells/m2 autologous HCMV-specific T cells by intravenous infusion. A minimum of 2 adoptive transfers will be given with the total number of infusions (up to a maximum of 6) dependent on the number of autologous HCMV-specific T cells generated.
Sponsors
QIMR Berghofer Medical Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or above 2. Informed consent. Approved hospital interpreters will be used for patients who do not have sufficient understanding of English for informed consent to be obtained without the use of an interpreter 3. ECOG performance status 0, 1, or 2 4. Life expectancy of at least 6 months 5. Histological diagnosis of GBM (WHO grade IV) 6. HCMV positive serology or positive staining for HCMV in tumour tissue 7. The patient will also complete the medical, and this will be co-signed by the clinical investigator
Exclusion criteria
1. Inability to identify an HCMV peptide to stimulate CTL cultures 2. Positive serology and NAT for HIV 3. Result indicating active HBV infection (N.B. Positive serology for HBV indicating previous but cleared infection with HBV would not be an exclusion criteria.) 4. Result indicating active HCV infection 5. Significant non–malignant disease (e.g. severe cardiac or respiratory dysfunction) 6. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial, as assessed by the clinical investigator 7. Prior cancers, except those diagnosed greater than 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than percent, or successfully treated nonmelanoma skin cancer, or carcinoma in situ of the cervix. 8. Receiving immunosuppressive therapy, except dexamethasone as given for normal management of symptoms related to their brain tumour and its treatment. 9. Lactating women, pregnancy, or unwilling to use adequate contraception.
Outcome results
None listed