This study is assessing the safety and tolerability of using T cell therapy targeting Human Cytomegalovirus (HCMV) in treating brain cancer (glioblastoma multiforme or GBM) alongside standard treatment.

Phase 1

Withdrawn

• Conditions: Glioblastoma multiforme (GBM); Cancer - Brain

• Registration Number: ACTRN12613000838718
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified