Refractory GlioblastomaPhase 2NCT04674527
Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma
A Phase 2 study testing Elemene and Temozolomide in people with Refractory Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Glioblastoma
- What is being tested?
- Elemene and Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: A Pilot Study of Elemene Injectable Emulsion in Treating Patients With Refractory Glioblastoma
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.
Read the 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
- Being tested
- Elemene, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElemeneDrug
Also called elemene injectable emulsion
Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.
TemozolomideDrug
Also called TMZ
Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival(OS)
Kaplan Meier methods will be used to estimate median OS.
Measured: 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.
Measured: 2 years.
Secondary outcomes (4)
objective response rate(ORR)
Objective Response Rate (ORR) will be assessed by comparison with baseline magnetic resonance imaging by RANO.
Measured: 2 years,up to 15 years if necessary.
complete response(CR)
Complete Response (CR) is disappearance of all measurable and non-measurable disease for at least 4 weeks.
Measured: 2 years,up to 15 years if necessary.
partial response
Partial Response (PR) is ≥ 50% decrease in lesions for at least 4 weeks.
Measured: 2 years,up to 15 years if necessary.
duration of response
Duration of Response (DOR) is the time between the initial response to the treatment and subsequent disease progression.
Measured: 2 years,up to 15 years if necessary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory GlioblastomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Normal University
- Responsible party
- Sponsor
- Investigators
- Jianmin Zhang, MD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674527
- Sponsor's protocol ID
- SAHZJU-RCT-ELEMENE
- Status last verified
- Dec 2020
- First submitted
- 17 Nov 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Elemene Injectable Emulsion in Treating Patients With Refractory Glioblastoma
- ClinicalTrials.gov ID
- NCT04674527
- Acronym / sponsor ID
- SAHZJU-RCT-ELEMENE
- Conditions
- Refractory Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Normal University
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Elemene, Drug: TemozolomideMaintenance 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. |
| contral group | Experimental | Drug: TemozolomideMaintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElemeneAlso: elemene injectable emulsionElemene injectable emulsion will be given for 80 mg/day in each 14-day cycle. | Drug | experimental group |
| TemozolomideAlso: TMZMaintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle. | Drug | contral group, experimental group |
Primary outcome
overall survival(OS)
Time frame: 2 years.
Kaplan Meier methods will be used to estimate median OS.
progression-free survival(PFS)
Time frame: 2 years.
Kaplan Meier methods will be used to estimate median PFS. Progression is defined by Response Assessment in Neuro-Oncology (RANO) criteria.
4 secondary outcomes
objective response rate(ORR)
Time frame: 2 years,up to 15 years if necessary.
complete response(CR)
Time frame: 2 years,up to 15 years if necessary.
partial response
Time frame: 2 years,up to 15 years if necessary.
duration of response
Time frame: 2 years,up to 15 years if necessary.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Refractory Glioblastoma
Active, not recruitingPhase 1
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
RecruitingPhase 1
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.
Advanced Solid Tumors, Recurrent or Progressive Glioblastoma
RecruitingPhase 1/2
Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
Solid Tumor Cancer, Medulloblastoma
Active, not recruitingPhase 1
IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM
Recurrent Glioblastoma, Refractory Glioblastoma
Active, not recruitingPhase 1
Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma
Glioblastoma, Malignant Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Zhang, MD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elemene and Temozolomide in people with Refractory Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Zhang, MD (8613805722695, 2307010@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival(OS) (time frame: 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.