ACTRN12609000736246
Withdrawn
Phase 1
Phase I trial of dendritic cell vaccination and celecoxib with postoperative radiotherapy and temozolomide for treatment of malignant glioma.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malignant glioma
- Sponsor
- Queensland Institute of Medical Research
- Enrollment
- 10
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Malignant glioma (World Health Organisation grade IV). Preoperative assessment by clinical presentation and Computed tomography (CT) / Magnetic Resonance Imaging (MRI) scans appearance of the lesion will identify suitable candidates. Progression to enrolment will be dependent upon the neuropathological diagnosis being confirmed.
- •2\. Age 18 – 75
- •3\. Macroscopic tumour resection (ie it was felt by the surgeon at operation that all visible tumour was resected; tumour seen on postoperative imaging does not exclude the patient from consideration)
- •4\. Patient undergoing standard postoperative radiotherapy and concurrent temozolomide chemotherapy, followed by post\-radiotherapy temozolomide.
Exclusion Criteria
- •1\. Presence of extensive intracranial or intraspinal disease which precludes total macroscopic or subtotal resection.
- •2\. Eastern Cooperative Oncology Group (ECOG) status \> 2
- •3\. Documented history of auto\-immune disease such as systemic lupus erythematosus (SLE), sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis. Previous use of long term immunosuppressive therapy in recent months. (NB perioperative short term
- •dexamethasone, which is normal treatment, does not preclude inclusion in the trial)
- •4\. Prior use of any immunotherapeutic agent.
- •5\. Serology indicating active infection with Hepatitis B or C, human immunodeficiency virus (HIV), human T\-cell leukemia virus\-1 (HTLV\-1\) or syphilis
- •6\. Significant non\-malignant disease (eg severe cardiac or respiratory dysfunction)
- •7\. Pregnancy
- •8\. Presence of another malignancy.
- •9\. Clinically relevant abnormal haematological and biochemical parameters (as assessed by the treating clinician).
Outcomes
Primary Outcomes
Not specified
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