Phase I Trial of Dendritic Cell Vaccination and Temozolomide for Recurrent Glioblastoma Multiforme

Phase 1

Completed

• Conditions: Glioblastoma Multiforme (GBM); Cancer - Brain

• Registration Number: ACTRN12611000029998
• Lead Sponsor: Malaghan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Able to give written informed consent and aged 18 or over.

2. Confirmed diagnosis of WHO Grade 4 Diffuse Astrocytoma (also known as Glioblastoma Multiforme) at original presentation and has relapsed.

3. Has completed treatment with external beam radiotherapy and concomitant Temozolomide, and at least the first 3 cycles of adjuvant Temozolomide.

4. Tumour is surgically accessible with acceptable risk of morbidity.

5. Has at least 1cm3 tumour tissue available as source for tumour antigen.

6. ECOG Performance Status = 2

7. Geographically accessible to the Wellington Blood and Cancer Centre and/or prepared to travel regularly to Wellington for treatment and follow-up for the duration of the study.

8. If fertile, prepared to use contraception for the duration of the trial. Postmenopausal women must have been amenorrhoea for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria

1. Pregnant or breastfeeding women.

2. Diagnosis of another malignancy within 5 years or presence of other serious unstable medical condition.

3. Serology indicating active infection with Hepatitis B or C, or HIV.

4. Uncontrolled or unstable auto-immune disease such as SLE, sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis.

5. 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).

6. Treatment with any chemotherapeutic agent other than Temozolomide since first diagnosis with GBM.

7. Concurrent major organ dysfunction, unstable medical condition, or significant abnormality of haematological, liver or renal function parameters.(Hb < 100 g/l, platelet count < 100 x 10^9/L, neutrophil count < 1.5x10^9/L , LFT or creatinine > 2 x upper limit normal).

8. Unfit for general anaesthesia.

9. Significant dysphasia or other neurological deficit likely to impair reliable communication between the participant and the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified