Phase I trial of dendritic cell vaccination and celecoxib with postoperative radiotherapy and temozolomide for treatment of malignant glioma.

Phase 1

Withdrawn

• Conditions: Malignant glioma; Cancer - Brain

• Registration Number: ACTRN12609000736246
• 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: 2009-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn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

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).
10. History of significant cardiac history (ie myocardial infarction < 1year, unstable angina).
11. Severe asthma or previous reactions to any non-steroidal anti-inflammatory medication.
12. If the patient is taking regular medications known to interact with celecoxib (lithium, warfarin, other Non-steroidal anti-inflammatory drugs).
13. Inadequate venous access for leukapheresis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: safety will be assessed by the incidence of adverse events considered to be associated with the experimental therapy (including haematology and biochemistry).[at weeks 6, 8, 10, 12, 14, 16, 22, 26, 30, 34, 28, 42, 52 post surgery]

Secondary Outcome Measures

Name	Time	Method
Tolerability: tolerability of the combined regimen will be assessed via quality of life measures.[at weeks 6, 8, 10, 12, 14, 16, 22, 26, 30, 34, 38, 42, 52 post surgery];General effects on the immune system of standard therapy and experimental intervention assessed by changes in cell counts and immune function in blood samples.[at weeks 2, 6, and 16 post surgery];Efficacy of vaccination on tumour growth will be assessed via magnetic resonance imaging (MRI) scans.[at weeks 1, 7, 19, 31 post surgery]