Open to recruitment
LUMOS2
Low & Anaplastic Grade Glioma Umbrella Study of Molecular Guided TherapieS
Summary
LUMOS2 is an innovative umbrella trial to address the unmet needs of people with relapsed G2/3 IDH-mutant glioma. Allocation to LUMOS2 treatment arms will be guided by genomic profiling results. Participants with a matched, targeted therapy will be provided the therapy through a LUMOS2 targeted treatment arm and participants who do not have an actionable molecular target, will be randomly allocated to a LUMOS2 treatment arm with a novel mechanism of action. Each treatment arm will recruit 19 patients and the primary objective of the study is to determine progression-free survival at six months.
Study Chair
Professor Hui Gan
c/o COGNO Coordinating Centre
Coordinating Centre
COGNO
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW, 1450
Australia
Email: lumos2.study@sydney.edu.au
Trial Status: Open to recruitment
For the November 2023 LUMOS2 update, please click here.
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.study@sydney.edu.au
Trial Status: Open to recruitment
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
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.study@sydney.edu.au
Trial Status: Funded. Protocol in development.
Closed to recruitment; Patients in follow up
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.study@sydney.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
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.study@sydney.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
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.study@sydney.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.study@sydney.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
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.study@sydney.edu.au
Trial Status: Closed
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.study@sydney.edu.au
Trial Status: Closed
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information
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.study@sydney.edu.au
Trial Status: Closed
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.study@sydney.edu.au
Trial Status: Closed
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: ctc.cogno@sydney.edu.au
Trial Status: Closed
Please refer to the Australian and New Zealand Clinical Trials Registry (ANZCTR) for additional information