ACTRN12615000656538
Completed
Phase 1
Phase I trial to assess the safety and tolerability of autologous CMV-specific T cells as adjuvant therapy for primary glioblastoma multiforme
QIMR Berghofer Medical Research Institute0 sites20 target enrollmentStarted: June 25, 2015Last updated:
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1\. Age 18 years or above
- •2\. Ability to provide informed consent.
- •3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at time of screening
- •4\. Life expectancy of at least 6 months
- •5\. Histological diagnosis of primary GBM (WHO grade IV)
- •6\. CMV\-positive serology or positive staining for CMV in tumour tissue
Exclusion Criteria
- •1\. Markers of active HBV, HCV, HIV, HTLV I and II or syphilis infection\* (presence of HbsAg, HCV antibody, HIV antibody, antibodies to HTLV I and II and positive serological test for syphilis, or positive nucleic acid testing \[NAT] for HIV, HBV or HCV)
- •2\. Significant non\-malignant disease (e.g. severe cardiac or respiratory dysfunction)
- •3\. Psychiatric, addictive or any conditions that may compromise the ability to participate in this trial, as assessed by the Clinical Investigator
- •4\. Prior cancers, except those diagnosed \>5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of \<5%, or successfully treated non\-melanoma skin cancer, or carcinoma in situ of the cervix.
- •5\. Receiving immunosuppressive therapy, except dexamethasone as given for normal management of symptoms related to the brain tumour and its treatment
- •6\. Women who are pregnant, lactating, or unwilling to use adequate contraception
- •\* N.B. Positive serology for HBV indicating previous but cleared infection with HBV is not an exclusion criterion.
Investigators
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