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Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

Primary Purpose

Refractory Glioblastoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Elemene

Temozolomide

About this trial

This is an interventional treatment trial for Refractory Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years; Male or Female.
Relapsed/refractory disease confirmed by radiographic evidence after standard therapy.
KPS ≥ 60
≥ 8 weeks after completion of front-line radiation therapy
≥ 6 weeks after completion of nitrourea chemotherapy
≥ 14 days after completion of Temozolomide or other chemotherapy
2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline
White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
Patients must be able to understand the investigational nature of the study and provide informed consent.

Exclusion Criteria:

Those who are allergic constitution, or have contraindications to CT and MRI1 contrast agents.
Those who plan to receive any other anti-tumor treatment during the trial.
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.
Patients with other malignant tumors.
Those with active infections, etc.
Suspected or confirmed a history of alcohol and drug abuse.
Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
Women who are pregnant or nursing.
Women of childbearing age who refuse to contraception.
Active participation in another clinical treatment trials.
According to the judgment of the investigator, other conditions that the plan cannot be followed.

Sites / Locations

Second Affiliated Hospital, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

experimental group

contral group

Arm Description

Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.And elemene injectable emulsion will be given for 80 -120 ml/day in each 14-day cycle or 21-day cycle.

Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.

Outcomes

Primary Outcome Measures

overall survival(OS)

Kaplan Meier methods will be used to estimate median OS.

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.

Secondary Outcome Measures

objective response rate(ORR)

Objective Response Rate (ORR) will be assessed by comparison with baseline magnetic resonance imaging by RANO.

complete response(CR)

Complete Response (CR) is disappearance of all measurable and non-measurable disease for at least 4 weeks.

partial response

Partial Response (PR) is ≥ 50% decrease in lesions for at least 4 weeks.

duration of response

Duration of Response (DOR) is the time between the initial response to the treatment and subsequent disease progression.

Full Information

NCT ID

NCT04674527

First Posted

November 17, 2020

Last Updated

December 16, 2020

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Hangzhou Normal University

1. Study Identification

Unique Protocol Identification Number

NCT04674527

Brief Title

Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Anticipated)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Hangzhou Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Arm Title

contral group

Arm Type

Experimental

Arm Description

Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.

Intervention Type

Drug

Intervention Name(s)

Elemene

Other Intervention Name(s)

elemene injectable emulsion

Intervention Description

Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

TMZ

Intervention Description

Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.

Primary Outcome Measure Information:

Title

overall survival(OS)

Description

Kaplan Meier methods will be used to estimate median OS.

Time Frame

2 years.

Title

progression-free survival(PFS)

Description

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.

Secondary Outcome Measure Information:

Title

objective response rate(ORR)

Description

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.

Title

complete response(CR)

Description

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.

Title

partial response

Description

Partial Response (PR) is ≥ 50% decrease in lesions for at least 4 weeks.

Time Frame

2 years,up to 15 years if necessary.

Title

duration of response

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years; Male or Female. Relapsed/refractory disease confirmed by radiographic evidence after standard therapy. KPS ≥ 60 ≥ 8 weeks after completion of front-line radiation therapy ≥ 6 weeks after completion of nitrourea chemotherapy ≥ 14 days after completion of Temozolomide or other chemotherapy 2 weeks of wash-out time after completion of targeted therapy with related adverse events (AE) on baseline White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%. Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment. Patients must be able to understand the investigational nature of the study and provide informed consent. Exclusion Criteria: Those who are allergic constitution, or have contraindications to CT and MRI1 contrast agents. Those who plan to receive any other anti-tumor treatment during the trial. 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. Patients with other malignant tumors. Those with active infections, etc. Suspected or confirmed a history of alcohol and drug abuse. Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator. Women who are pregnant or nursing. Women of childbearing age who refuse to contraception. Active participation in another clinical treatment trials. According to the judgment of the investigator, other conditions that the plan cannot be followed.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jianmin Zhang, MD

Phone

8613805722695

2307010@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jianmin Zhang, MD

Organizational Affiliation

Second Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Study Chair

Facility Information:

Facility Name

Second Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

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