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

Phase 1

Completed

• Conditions: glioblastoma multiforme; Cancer - Brain

• Registration Number: ACTRN12609000338268
• Lead Sponsor: Queensland Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified