ACTRN12613000838718
Withdrawn
Phase 1
Phase I/II trial to assess safety and tolerability of autologous HCMV-specific T cell therapy as adjuvant treatment for glioblastoma multiforme.
QIMR Berghofer Medical Research Institute0 sites25 target enrollmentStarted: July 30, 2013Last updated:
Overview
- Phase
- Phase 1
- Status
- Withdrawn
- Enrollment
- 25
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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.
Investigators
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