Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

Refractory Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04674527
• Other study ID #: SAHZJU-RCT-ELEMENE
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jianmin Zhang, MD
• Phone: 8613805722695
• Email: 2307010[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years; Male or Female.

2. Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.

3. KPS = 60

4. = 8 weeks after completion of front-line radiation therapy

5. = 6 weeks after completion of nitrourea chemotherapy

6. = 14 days after completion of Temozolomide or other chemotherapy

7. 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline

8. White blood cell count (WBC) = 3.0 x 109/L; peripheral blood lymphocyte (PBL) = 25%.

9. Echocardiographic assessment of left ventricular ejection fraction (LVEF) = 40% within 1 month of enrollment.

10. Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

1. Those who are allergic constitution, or have contraindications to CT and MRI1 contrast agents.

2. Those who plan to receive any other anti-tumor treatment during the trial.

3. Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.

4. Patients with other malignant tumors.

5. Those with active infections, etc.

6. Suspected or confirmed a history of alcohol and drug abuse.

7. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.

8. Women who are pregnant or nursing.

9. Women of childbearing age who refuse to contraception.

10. Active participation in another clinical treatment trials.

11. According to the judgment of the investigator, other conditions that the plan cannot be followed.

Related Conditions & MeSH terms

• Glioblastoma
• Refractory Glioblastoma

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou Normal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival(OS)	Kaplan Meier methods will be used to estimate median OS.	2 years.
Primary	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.	2 years.
Secondary	objective response rate(ORR)	Objective Response Rate (ORR) will be assessed by comparison with baseline magnetic resonance imaging by RANO.	2 years,up to 15 years if necessary.
Secondary	complete response(CR)	Complete Response (CR) is disappearance of all measurable and non-measurable disease for at least 4 weeks.	2 years,up to 15 years if necessary.
Secondary	partial response	Partial Response (PR) is = 50% decrease in lesions for at least 4 weeks.	2 years,up to 15 years if necessary.
Secondary	duration of response	Duration of Response (DOR) is the time between the initial response to the treatment and subsequent disease progression.	2 years,up to 15 years if necessary.