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Phase I trial of the safety and the effect on immune parameters of an immunotherapy for glioma based on cultured autologous dendritic cells presenting autologous tumour cell antigens derived from irradiated glioma cells

Phase I trial of the safety and the effect on immune parameters of an immunotherapy for glioma based on cultured autologous dendritic cells presenting autologous tumour cell antigens derived from irradiated glioma cells

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000423617
Acronym
RMQ0331
Enrollment
10
Registered
2005-09-16
Start date
2003-06-30
Completion date
Unknown
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

Interventions

Autologous dendritic cell vaccine using autologous irradiated cells as antigen source administered at 2 weekly intervals for the first 6 injections, then 6 weekly thereafter, for 1 year or until disease progression.

Sponsors

Queensland Institute of Medical Research (QIMR)
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
1 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Confirmed Malignant Glioma, Macroscopic tumour resection, normal haematolological parameters, acceptable liver and renal function parameters.

Exclusion criteria

Extensive intracranial disease precluding total or subtotal resection, ECOG status >2, History of autoimmune disease or immunosuppressive therapy, Prior use of immunotherapeutic agent, Positive serology for HIV, Hep B or Hep C, Significant non-malignant disease, Pregnancy, Other malignancy, Patients in whom only biopsy or partial resection was possible.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026