Trial purpose
Cancer treatment
Tumor type
Brain and Spinal
Age
18+
Clinical summary
Summary
This study aims to evaluate the safety and effectiveness of a combination of veliparib with radiotherapy, followed by a combination of veliparib with temozolomide (a chemotherapy), to treat patients with newly diagnosed glioblastoma multiforme (a type of brain tumour). Who is it for? You can join this study if you are a person who is recently diagnosed with glioblastoma multiforme (brain tumour), underwent surgery (or have been scheduled to undergo surgery) for this diagnosis and are considered for further treatment with radiotherapy plus temozolomide treatment. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive veliparib together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with a combination of temozolomide and veliparib. Group 2 will receive receive temozolomide together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with temozolomide. Your chance to receive the group 1 treatment is twice as high as to receive the group 2 treatment. Participants will be asked to attend clinic visits every 2-4 weeks during the treatment period and then two times more (1 month and 3 months after having received the last treatment). During these visits the specialist will assess the status of your glioblastoma and your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, urine testing, scans, and questionnaire completion and to give tissue samples for laboratory research.
Conditions
This trial is treating people with Glioblastoma
Eligibility
Inclusion
1) Adults, aged 18 years or older, newly diagnosed histologically confirmed GBM (WHO grade IV glioma) following surgery, with unmethylated MGMT promoter gene whom are considered suitable for radiotherapy (RT) plus concurrent temozolomide (TMZ), followed by adjuvant temozolomide (TMZ)
NOTE - Patients who undergo biopsy only are eligible only if standard RT and TMZ treatment is considered appropriate;
2) Available tissue for MGMT and biomarker analysis;
3) ECOG 0-2 if 70 years or younger, or ECOG 0 if older than 70 years;
4) Life expectancy of more than 12 weeks;
5) Adequate bone marrow function (platelets greater than 100 x 109/L, ANC greater than 1.5 x 109/L);
6) Adequate liver function (ALT/AST less than 1.5 x ULN);
7) Adequate renal function (creatinine clearance greater than 50 ml/min measured using Cockroft-Gault see appendix 16.4);
8) Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
9) Signed, written informed consent.
Exclusion
1) Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may impact with the administration of study related treatments or procedures;
2) Other co-morbidities or conditions that may compromise assessment of key outcomes;
3) No prior chemotherapy or recent cranial radiation within the last 2 years. No other prior or concomitant therapies for GBM allowed, excepting surgery
NOTE - Patients who had previous grade I-III glioma and have progressed to GBM are eligible assuming that they have not received prior cranial radiotherapy or TMZ for the treatment of glioma;
4) History of another malignancy within 2 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 2 years after definitive primary treatment.
NOTE - Patients with localised cancer free of metastatic disease and of very low risk of recurrence are eligible. Eligibility of patients with localised cancer must be confirmed by the Study Chair.
5) Significant infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated;
6) Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety;
7) Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol;
8) 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;
9) Patients with a duration of more than 7 weeks from surgery to the start of RT.
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.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Cure Brain Cancer Foundation
Scientific Title
A Randomised Phase II study of veliparib and radiotherapy with adjuvant temozolomide and veliparib versus standard radiotherapy and temozolomide followed by temozolomide in patients with newly diagnosed glioblastoma with unmethylated O (6)-methylguanine-DNA methyltransferase
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