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Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04674527
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jianmin Zhang, MD
Principal Investigator Affiliation Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Refractory Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

Experimental: experimental group

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.

Experimental: contral group

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Address

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009

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