NCT04674527

Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

A Pilot Study of Elemene Injectable Emulsion in Treating Patients With Refractory Glioblastoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Glioblastoma

Interventions

Type	Name	Description
DRUG	Elemene	Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.
DRUG	Temozolomide	Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-12-19
• Last updated: 2020-12-19

Locations

1 site across 1 country: China