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MAGMA

The Multi-Arm GlioblastoMa Australasia (MAGMA) Trial

Summary

The MAGMA trial is a platform trial that will aim to assess a number of options in standard of care for the management of glioblastoma. Initial questions of interest are i) whether or not to give daily temozolomide as soon as possible after surgery prior to chemoradiotherapy (CRT) and ii) whether to give 6 cycles of temozolomide after CRT, or continue monthly treatment until disease progression.
 
Study Chair

Associate Professor Craig Gedye
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: magma@ctc.usyd.edu.au

Trial Status: Open to recruitment
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
 
 
 
In development
 
PersoMed-I

Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly-Diagnosed Medulloblastoma (PersoMed-I)

Summary

PersoMed-I is phase II, randomised international trial of personalised therapy, including sonidegib, for adolescents and young adults with SHH pathway activated medulloblastoma.
 
Study Co-Chairs

Associate Professor David Ziegler and Associate Professor Liz Hovey
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: persomed@ctc.usyd.edu.au

Trial Status: Funded. Protocol in development.
 
 
 
 
PICCOG

PARP and Immune Checkpoint Inhibitor COmbination for relapsed IDH-mutant high-grade Glioma

Summary

PICCOG is a phase II single arm trial that will determine the activity of a PARP inhibitor and an immune checkpoint inhibitor (nivolumab) against relapsed IDH-mutant high-grade glioma.
 
Study Chair

Dr Hao-Wen Sim
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: piccog@ctc.usyd.edu.au

Trial Status: Funded. Protocol in development.
 
 
 
 
Closed to recruitment; Patients in follow up
 
NUTMEG

A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma

Summary

The aim of the study is to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes of GBM patients who are 65 years of age or older.

Study Chair
 
Associate Professor Mustafa Khasraw
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: nutmeg@ctc.usyd.edu.au

Trial Status: Closed to recruitment; Patients in follow up
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
 
 
 
LUMOS

Low & Intermediate Grade Glioma Umbrella Study of Molecular Guided TherapieS

Summary

Low and intermediate grade brain tumour are universally fatal brain tumours with almost no access to clinical trials. LUMOS is a comprehensive Australian trials program for these patients. We will match tumours on a molecular level with the best treatments. We will assist in accessing these drugs, including creating trials of new treatments. Lastly, we will collect an invaluable set of tissue and blood before and after treatment for future research into better treatments.
 
Study Chair

Associate Professor Hui Gan
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: lumos@ctc.usyd.edu.au

Trial Status: Closed to recruitment; Patients in follow up
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
 
 

ACED

Acetazolamide plus Dexamethasone versus dexamethasone alone in recurrent and/or progressive HGG

Summary

To explore whether the addition of oral acetazolamide allows for dexamethasone dose reduction without clinical deterioration in performance status in the management of raised intracranial pressure in recurrent and/or progressive High Grade Glioma (HGG).

Study Chair
 
Professor Meera Agar 
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: aced@ctc.usyd.edu.au

Trial Status: Closed to recruitment; Patients in follow up
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
 
 

VERTU

VEliparib, Radiotherapy and Temozolomide trial in Unmethylated MGMT Glioblastoma. A Randomised Phase II study of veliparib + radiotherapy (RT) with adjuvant temozolomide (TMZ) + veliparib versus standard RT + TMZ followed by TMZ in patients with newly diagnosed glioblastoma (GBM) with unmethylated O (6)-methylguanine-DNA methyltransferase (MGMT)

Summary

To evaluate the combination of the PARP inhibitor veliparib with radiotherapy and adjuvant temozolomide to improve progression-free and survival outcomes of GBM patients with unmethylated MGMT.

Study Chair
 
Associate Professor Mustafa Khasraw
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: vertu@ctc.usyd.edu.au

Trial Status: Closed to recruitment; Patients in follow up
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
 
 
 
CATNON

Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup trial

Summary

The main purpose of this study is to determine whether chemotherapy given in addition to radiotherapy or the addition of chemotherapy after the completion of radiotherapy will improve overall survival and the time until tumour progression. Further, this study aims to find out the effects of chemotherapy when either given at the same time as radiotherapy or after finishing radiotherapy. The second major objective is to identify patients most likely to benefit from this specific treatment based on molecular markers analysed on the tumour specimen previously resected which will ultimately allow the development of new treatments more specific for each patients tumour characteristics.

Study Chair

Professor Anna Nowak
School of Medicine and Pharmacology
Sir Charles Gairdner Hospital
4th Floor, G block
Hospital Ave
Nedlands
WA 6009

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: catnon@ctc.usyd.edu.au

Trial Status: Closed to recruitment; Patients in follow up
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
  
 
 
Closed
 
SEED

Self-reported evaluation of the adverse effects of dexamethasone

Summary

This is not an interventional study but a feasibility study measuring patient reported outcomes (PROs) in the evaluation of side effects and toxicities from steroid use in patients with brain tumours or brain metastases or advanced cancer.  A multicentre cohort study with patient (including PRO measures), caregiver and clinician measures. Data will inform the baseline measures for a clinical study that will investigate whether acetazolomide, a steroid sparing agent can reduce the need for steroids and therefore reduce the side effects associated with steroid use.

Study Chair
 
Dr Meera Agar
Braeside Hospital
Dept of Palliative Care
340 Prairievale Road
Prairiewood
NSW 2164

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: seed@ctc.usyd.edu.au

Trial Status: Closed
 
Trial results have been published in a journal article: Validating self-report and proxy reports of the Dexamethasone Symptom Questionnaire - Chronic for the evaluation of longer-term corticosteroid toxicity. Article available on
http://link.springer.com/article/10.1007/s00520-015-2897-0

Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
 
  
 
  
CABARET
 
A randomised phase II study of Carboplatin and Bevacizumab in Recurrent Glioblastoma Multiforme

Summary

To determine the effect of the combination of bevacizumab plus carboplatin versus bevacizumab alone on progression-free survival (using modified RANO criteria) in patients with recurrent grade IV glioma (glioblastoma multiforme).

Study Chair
 
Dr Kathryn Field
c/o COGNO Coordinating Centre

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: cabaret@ctc.usyd.edu.au

Trial Status: Closed

For the trial result summary, please click here.
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information 
 
 
 
 
Temozolomide/Caelyx

Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy

Summary

Phase II Trial of six months of oral Temozolomide (200mg/m2 days 1-5, 4 weekly) and intravenous liposomal doxorubicin (40mg/m2 4 weekly) (Caelyx) in standard doses in the Treatment of Patients with Glioblastoma Multiforme (GBM) following concurrent radiotherapy and chemotherapy to improve six month progression free survival. The purpose of the study is to evaluate the efficacy and toxicity of combination Temozolomide and Caelyx in patients with GBM following concurrent radiotherapy and chemotherapy.

Study Chair

Professor Mark Rosenthal
Royal Melbourne Hospital
Grattan Street
Parkville
Victoria
Australia 3050

Coordinating Centre

COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: cogno@ctc.usyd.edu.au

Trial Status: Closed
 
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information