Phase I trial to assess safety of autologous Human Cytomegalovirus (HCMV) -specific T cell therapy for glioblastoma multiforme (GBM)

Phase I trial to assess safety of autologous Human Cytomegalovirus (HCMV)-specific T cell therapy for glioblastoma multiforme

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000338268

Enrollment

Registered

2009-05-22

Start date

2009-11-09

Completion date

2014-02-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study looks at the safety and effectiveness of using T cell therapy targeting Human Cytomegalovirus (HCMV) in treating brain cancer (glioblastoma multiforme or GBM). Who is it for? You can join this study if you have brain cancer (glioblastoma multiforme) that has progressed or recurred since it was first diagnosed. Trial details Participants 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 is 4 fortnightly infusions, 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 and kill 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

Autologous HCMV-specific T cell therapy administered by fortnightly intravenous infusion. A minimum of 3 infusions and a maximum of 4. The number of infusions will depend on the number of autologous HCMV-specific CTL generated. Between 25 to 40 x 106 cells are required per infusion.

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

Inclusion criteria

1. Age 18 years or above. 2. Geographically accessible for follow up 3. Informed consent. 4. ECOG (Eastern Cooperative Oncology Group) performance status 0, 1, 2 or 3 5. Life expectancy of at least 3 months 6. Previous histological diagnosis of GBM (WHO (World Health Organization) grade IV) and radiological and/or clinical evidence of tumour progression or recurrence

Exclusion criteria

1. HCMV negative serology 2. Positive serology for HIV (Human Immunodefficiency Virus) 3. Serology indicating active HBV infection or carrier status for HBV. 4. Serology indicating active HCV infection 5. Significant non–malignant disease 6. Psychiatric, addictive or any conditions which may compromise the ability to participate in this trial 7. 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. 8. Receiving immunosuppressive therapy, including corticosteroids. 9. Pregnancy, or unwilling to use adequate contraception.

Outcome results