A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurren… (NCT03234595) | Clinical Trial Compass
CompletedPhase 1/2
A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma
Taiwan22 participantsStarted 2017-11-01
Plain-language summary
Cerebraca Wafer (75 mg \[(Z)-n-butylidenephthalide\]) is designed for surgical combination to treat glioblastoma (GBM) diseases. High-grade glioma includes GBM (Grade IV, isocitrate dehydrogenase 1 \[IDH1\] wild-type) and anaplastic astrocytoma (Grade IV and Grade III, IDH1 mutation). Among these, GBM is the most common and aggressive brain tumor. Patient suffering from GBM usually develops symptoms such as headaches, seizures, memory loss, and changes in behavior in its early phase. At later stages, patients may encounter loss of movement and sensation, language dysfunction, and cognitive impairments depending on location and size of the tumor. The average survival of recurrent GBM patients is 6 to 9 months regardless of the use of current available therapies.
The clinical trial aimed to evaluate the safety and efficacy profiles of Cerebraca Wafer plus adjuvant TMZ in patients with recurrent GBM. Additionally, the study sought to determine the maximum tolerated dose (MTD) of Cerebraca Wafers. This study specifically examined the safety of the intended dose of 6 wafers.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female or male, age ≥ 20 years old
. Patient has diagnosed recurrent high grade glioma, including anaplastic astrocytoma and glioblastoma multiforme
. Patients have enough cavity after glioma resection for planned number of wafer implantation (by Investigator's judgment)
. Patients have unilateral single focus of tumor in cerebrum
. Patients have the 1st time recurrence of glioma
. Patients undergone standard therapy for their prior glioma episode; for patients with anaplastic astrocytoma, the prior standard therapy should include surgical resection, radiation and adjuvant temozolomide (or PCV \[procarzine, lomustine and vincristine\]; for patients with glioblastoma multiforme the prior standard therapy should include surgical resection, radiation and adjuvant temozolomide
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the maximum tolerated dose (MTD) of Cerebraca Wafer by dose limiting toxicity (DLT) in patients with recurrent high-grade glioma.
Timeframe: 2 year
2
To evaluate the efficacy profiles of Cerebraca Wafer in patients with recurrent high-grade glioma.
. Patients with Karnofsky Performance Score (KPS) ≥ 50
. Patients are recovered from toxicities from prior systemic therapies and have adequate hematopoietic function at screening and before using study medication
Exclusion criteria
. Patient who has participated in other investigational studies within 4 weeks prior to receive Cerebraca wafer
. Patient with known or suspected hypersensitivity to Cerebraca wafer, TMZ or the excipient
. Patient has tumor that cannot be surgically removed without significantly affecting vital function
. Patient's glioma locates in the area that is not suitable for Cerebraca wafer implantation
. Patient has external-beam radiation therapy within 4 weeks before study entry
. Patient has other severe and/or life-threatening disease(s) with life expectancy less than 12 months
. Patient has immuno-compromised condition, or is with known autoimmune conditions or is human immunodeficiency virus (HIV) seropositive.
. Patient with medical, social or psychological factors interfering with compliance of the study