A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
A Phase I/IIa Study to Determine the Maximum Tolerated Dose (MTD) and to Evaluate the Safety
and Efficacy Profile of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With
Recurrent High Grade Glioma.
High grade gliomas, glioblastoma multiforme (grade IV) and anaplastic anaplastic astrocytoma
(Grade III), are the most comment malignant brain tumor. The cause of gliomas remains
unknown. Despite of several researches on environmental hazards and genetic alterations, no
direct causes were found.
Patient suffering from glioma 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 glioblastoma patients is 15 months
regardless of the use of multimodal therapy.
(Z)-BP/polymer wafer, designated as Cerebraca wafer, is a biodegradable wafer for
interstitial implantation comprises (Z)-n-butylidenephthalide ((Z)-BP; the active moiety) and
Carboxyphenoxypropane-Sebacic Acid Copolymer (CPPSA; the excipient).
Cerebraca wafer, the first human-use drug product, is a biodegradable implant comprises
(Z)-n-butylidenephthalide ((Z)-BP) and CPPSA. According to pre-clinical study, (Z)-BP could
reduce glioma migration and invasion, it also could reduce the tumor stem cell marker gens.