This is a pilot phase I study to evaluate the safety and efficacy on elemene injectable emulsion in treating patients with glioblastoma. Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo.Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs.
Background * Elemene, isolated from the Chinese medicinal herb Curcuma wenyujin, was shown to exhibit antitumor activity in human and murine tumor cells in vitro and in vivo * The study shows that the methodological quality of RCTs of Elemene injectable emulsion against malignant tumors was low. Therefore, the effect of Elemene injectable emulsion being used in clinical settings needs to be confirmed by further RCTs Objectives * To evaluate the safety of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ * To evaluate the efficacy of Elemene injectable emulsion to treat Refractory Glioblastoma with TMZ Design This clinical trail is a randomized controlled trial.In control group,patients will receive TMZ-chemotherapy.In experimental group,patients will receive elemene injectable emulsion and TMZ-chemotherapy at the same time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.
Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
overall survival(OS)
Kaplan Meier methods will be used to estimate median OS.
Time frame: 2 years.
progression-free survival(PFS)
Kaplan Meier methods will be used to estimate median PFS. Progression is defined by Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame: 2 years.
objective response rate(ORR)
Objective Response Rate (ORR) will be assessed by comparison with baseline magnetic resonance imaging by RANO.
Time frame: 2 years,up to 15 years if necessary.
complete response(CR)
Complete Response (CR) is disappearance of all measurable and non-measurable disease for at least 4 weeks.
Time frame: 2 years,up to 15 years if necessary.
partial response
Partial Response (PR) is ≥ 50% decrease in lesions for at least 4 weeks.
Time frame: 2 years,up to 15 years if necessary.
duration of response
Duration of Response (DOR) is the time between the initial response to the treatment and subsequent disease progression.
Time frame: 2 years,up to 15 years if necessary.
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