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RecruitingLast updated: 3 May 2024

MAGMA: This phase III trial is trying to understand whether to give glioblastoma patients chemotherapy as soon as possible following surgery and prior to chemoradiotherapy; and how many cycles of standard adjuvant chemotherapy to give patients after chemoradiotherapyA multi-arm multi-stage, multi-centre, phase III (MAMS) platform trial that aims to assess hypotheses against a common standard-of-care control arm for the management of people with glioblastoma

Clinical summary

Summary

This trial is trying to understand: (1) whether to give metronomic temozolomide as soon as possible following surgery and prior to chemoradiotherapy; and (2) whether to give 6 cycles of standard schedule adjuvant temozolomide chemotherapy (5/28 day cycles) after chemoradiotherapy, or continue temozolomide until progression. Patients will be randomised to a specific arm of treatment, unless they decide not to participate in the randomisation process and are instead assigned to an arm at their clinician's discretion.

Conditions

This trial is treating patients with glioblastoma

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18+

Phase

III

Trial Acronym

MAGMA

More information

Trial Identifiers

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Trial sponsor

National Health & Medical Research Council (NHMRC)

Scientific Title

A multi-arm multi-stage, multi-centre, phase III (MAMS) platform trial that aims to assess hypotheses against a common standard-of-care control arm for the management of people with glioblastoma

Eligibility

Inclusion

1. Adults, aged 18 years and older, with newly diagnosed histologically confirmed grade IV malignant glioblastoma (any IDH mutation status) or glioma with molecular features of GBM (e.g. IDH-wildtype grade III high grade glioma, which have been confirmed to have the same prognosis as glioblastoma (grade IV) patients, and are now functionally treated as GBM39)
2. Adequate recovery from surgical resection
3. ECOG performance status of 0-2
4. Previous surgery for a low-grade glioma is allowed, if there was no radiation or chemotherapy administered at that time
5. Adequate bone marrow function (platelets greater than or equal to 100 x 109/L, ANC greater than or equal to 1.5 x 109/L)
6. Adequate liver function (ALT/AST less than 3 x ULN)
7. Adequate renal function (creatinine clearance greater than 30ml/min)
8. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
9. Signed, written informed consent

Exclusion

 1. Recurrence of glioblastoma
2. Comorbidities considered to provide a safety concern for use of TMZ, e.g. idiopathic
autoimmune thrombocytopenia or other haematological diease causing cytopaenias
3. Other contraindications to TMZ
4. Cranial irradiation within 2 years prior to registration
5. Other co-morbidities or conditions that may compromise assessment of key outcomes
6. History of another malignancy within 2 years prior to registration. Patients with adequately treated carcinoma-in-situ of the prostate, breast or cervix, melanoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive transitional cell carcinoma of the bladder or low grade prostate cancer not requiring treatment (ISUP 1; Gleason grade less than or equal to 6) may be included in this study.
7. Concurrent illness, including severe or chronic bacterial or viral infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety. Patients with adequately treated hepatitis B, hepatitis C or human immunodeficiency virus at low risk of acquired immunodeficiency syndrome-related outcomes may be included in this study.
8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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