Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma

NCT04674527 | Unknown Phase 2

• 1 other identifier: SAHZJU-RCT-ELEMENE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Glioblastoma

Outcome Measures

Primary Outcomes (2)

• overall survival(OS)

  Kaplan Meier methods will be used to estimate median OS.

  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.

  2 years.

Secondary Outcomes (4)

• objective response rate(ORR)

  2 years,up to 15 years if necessary.

• complete response(CR)

  2 years,up to 15 years if necessary.

• partial response

  2 years,up to 15 years if necessary.

• duration of response

  2 years,up to 15 years if necessary.

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Drug: Elemene; Drug: Temozolomide

contral group

EXPERIMENTAL

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

Drug: Temozolomide

Interventions

Elemene DRUG

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

Also known as: elemene injectable emulsion

experimental group

Temozolomide DRUG

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

Also known as: TMZ

contral group; experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Hangzhou Normal University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

elemene; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jianmin Zhang, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Jianmin Zhang, MD

CONTACT

8613805722695; 2307010@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 19, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)