BridgeMD
BORTEM 17
EU CTIS ID: 2024-515142-16-00
What this study is testing
Phase IB: Assessment of safety and tolerability of Bortezomib administered with Temozolomide. Determination of the optimal dose of TMZ and BTZ given as combination therapy. Sample size 10 patients. Phase II: Assessment of efficacy of Bortezomib administered with Temozolomide. Sample size 53 patients.Estimation of the median progression free survival (PFS) and overall survival (OS) of patients with recurrent or progressed grade-4 glioma after pre-treatment with Bortezomib prior to combination with Temozolomide as well as progression free rate at 6 months
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed recurrent or progressed WHO grade IV intracranial IDH wildtype glioblastoma (GBM) or grade IV IDH mutated astrocytoma, MRI evidence of recurrence within 14 days prior to enrolment
- Written informed consent for study participation and tumour, blood sample collection obtained before performance of any study related procedure
- Karnofsky performance status ≥ 70%
- WBC ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
You likely can't join if
- Hypersensitivity to Bortezomib, boron, or mannitol
- Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Serious medical or psychiatric illness that would interfere with study participation including, but not limited to, any of the following: - Psychiatric illness and/or social situations that would limit compliance with study requirements - Ongoing, uncontrolled infection requiring IV antibiotics - Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus) - History of stroke within the past 6 months - Other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy
- Significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Disease that will obscure toxicity or dangerously alter drug metabolism
- Viral hepatitis (HBV surface antigen positive) or active hepatitis C infection
See the full eligibility criteria
Who can join
- Histologically confirmed recurrent or progressed WHO grade IV intracranial IDH wildtype glioblastoma (GBM) or grade IV IDH mutated astrocytoma, MRI evidence of recurrence within 14 days prior to enrolment
- Written informed consent for study participation and tumour, blood sample collection obtained before performance of any study related procedure
- Karnofsky performance status ≥ 70%
- WBC ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Prothrombin time/international normalized ratio (PT INR) < 1.4.
- Haemoglobin ≥ 10 g/dL (transfusion allowed)
- Adequate hepatic function: serum bilirubin, AST, ALT and alkaline phosphatase ≤ 2.5 upper limit of normal (ULN)
- Serum potassium within normal limit
- Serum sodium > 130 mmol/L
- Unmethylated MGMT promoter characterised from tissue obtained at operation
- Estimated GFR ≥ 60
- Stable or reduced doses of corticosteroids for at least 1 week prior to enrolment, but analgesics and other drugs to treat symptoms or prevent complications allowed
- Patients receiving EIAED must be transitioned to non-EIAED at least 2 weeks before study inclusion
- Unfractionated and/or low molecular weight heparin is allowed
- Other investigational drugs must be discontinued at least 12 weeks prior to study entry unless treatment failure under other experimental therapy is confirmed. If progression during other experimental therapy is confirmed the time interval between previous treatment and BORTEM-17 may be reduced to 4 weeks
- Eligibility for standard therapy with Temozolomid as 5-days treatment q4w.
- Negative pregnancy test no longer than 14 days prior to enrollment
- Women of childbearing potential (WOCBP) defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile must use adequate contraception. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy
- Men in sexual relationship with WOCBP must agree to use a condom during treatment and until 3 months after the last dose of bortezomib and 6 months after the last dose of TMZ
- Must submit an unstained paraffin block and/or cryopreserved tumour tissue from surgical procedure
- Must be >- 18 years old, with a life expectancy > 8 weeks
- Radiologically (MRI) confirmed tumour relapse/progression ≥ 12 weeks since completed radiotherapy
- Measurable recurrent tumour
- Tumour not available for radiosurgery
- Patients previously treated with radiosurgery er eligible for the study
- If previously treated with gammaknife, at least one evaluable lesion outside the irradiated area is required, unless the time after the radiosurgery is 12 weeks or more
What rules you out
- Hypersensitivity to Bortezomib, boron, or mannitol
- Electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Serious medical or psychiatric illness that would interfere with study participation including, but not limited to, any of the following: - Psychiatric illness and/or social situations that would limit compliance with study requirements - Ongoing, uncontrolled infection requiring IV antibiotics - Disorders associated with a significant immunocompromised state (e.g., HIV, systemic lupus erythematosus) - History of stroke within the past 6 months - Other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy (i.e., cervical cancer), or low-risk prostate cancer after curative therapy
- Significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Disease that will obscure toxicity or dangerously alter drug metabolism
- Viral hepatitis (HBV surface antigen positive) or active hepatitis C infection
- Concurrent investigational drugs (chemotherapy) must be stopped at least 12 weeks prior to therapy or treatment failure under other experimental therapy must be confirmed before study entry. If progression during previous experimental therapy is confirmed the time interval before BORTEM-17 study entry may be reduced to 6 weeks.
- Concurrent use of any inducers of CYP450 3A4 including, but not limited to enzyme-inducing anti-epileptic drugs [EIAED] e.g. phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone.
- Another ongoing experimental therapy
- Any contraindications for use of Temozolomid
- Peripheral neuropathy ≥ grade 2
- Previous treatment with bevacizumab or lomustine either as monotherapy or in combination with procarbazine and vincristine for ralapsed glioblastoma (PCV as primary treatment of low grade oligodendroglioma, before development of glioblastoma is allowed)
- Myocardial infarction within the past 6 months
- NYHA class III or IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Known heart failure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.