GlioblastomaPhase 2NCT02330991
A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse
A Phase 2 study testing Temozolomide in people with Glioblastoma, run by Beijing Sanbo Brain Hospital.
Trial summary
The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous dose-intense regimen）in patients with glioblastoma at first relapse. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histopathologically-confirmed, supratentorial, glioblastoma.
- Participants must have received first-line treatment regimen consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide.
- Participants must be first recurrence or progression of glioblastoma after first-line treatment regimen.
- Participants must have demonstration of recurrent disease on MRI following prior therapy.
- Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm in one dimension on MRI performed within 14 days prior to first treatment. If receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI.
- Participants must have developed progressive disease after receiving prior therapy and must have an interval of at least 12 weeks from the completion of radiation and concomitant temozolomide therapy to study entry (unless progressive tumor growth is outside the radiation field or there is histopathological confirmation of recurrent tumor)
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- Age 18-75 years old.
- Life expectancy of at least 12 weeks.
- Karnofsky performance status at least 60
- Participants must be able to adhere to the dosing and visit schedules, and agree to record medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary.
- 20 paraffinsections of glioblastoma tissue must be available.
- Participants must have normal organ and marrow function as defined below: leukocytes >4.0×10^9/L，platelets >100×10^9/L，Hemoglobin > 10 g/dl，Serum creatinine< 1.5-fold upper normal range，AST and ALT <2-fold upper normal range, Alkaline phosphatase < 3-fold upper normal range.
- Female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception.
Who cannot join
- Treatment with any chemotherapy other than temozolomide prior to enrollment.
- Progressive or recurrent glioblastoma documented by MRI earlier than 12 weeks after completion of radiotherapy.
- History of any other cancer.
- HIV infection.
- Women who are pregnant or breast feeding.
About this study
The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous dose-intense regimen）in patients with glioblastoma at first relapse.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide
- Keywords
- glioblastoma, relapse, Temozolomide, glioblastoma at first relapse
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodal
| Study group | Role | What they receive |
|---|---|---|
| Arm1 ,one-week on/one-week off regimen | Experimental | One-week on/one-week off regimen is administered for 12 cycles of 28 days. Arm 1 receives temozolomide 150 mg/m2 daily during days 1 to 7 and 15 to 21 of each cycle.Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles. Receives: Drug: Temozolomide |
| Arm 2,continuous dose-intense regimen | Experimental | Continuous dose-intense regimen is administered for 12 cycles of 28 days .Arm 2 receives temozolomide 50mg/m2 daily during days 1 to 28 of each cycle. Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles. Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-Free Survival at 6 months (PFS6)
Measured: 6 months
Secondary outcomes (4)
Overall Survival(OS)
Measured: 2 years
Progression free survival
Measured: 2 years
Objective Response Rate
Measured: up to 52 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junping Zhang, Beijing Sanbo Brain Hospital
- Investigators
- Junping Zhang, MD, Principal investigator, Beijing Sanbo Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330991
- Sponsor's protocol ID
- 2014062501
- Status last verified
- Jul 2023
- First submitted
- 30 Dec 2014
- Last updated
- 24 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse
- ClinicalTrials.gov ID
- NCT02330991
- Acronym / sponsor ID
- 2014062501
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, relapse, Temozolomide, glioblastoma at first relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous dose-intense regimen）in patients with glioblastoma at first relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 ,one-week on/one-week off regimen | Experimental | Drug: TemozolomideOne-week on/one-week off regimen is administered for 12 cycles of 28 days. Arm 1 receives temozolomide 150 mg/m2 daily during days 1 to 7 and 15 to 21 of each cycle.Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles. |
| Arm 2,continuous dose-intense regimen | Experimental | Drug: TemozolomideContinuous dose-intense regimen is administered for 12 cycles of 28 days .Arm 2 receives temozolomide 50mg/m2 daily during days 1 to 28 of each cycle. Treatment will continue until tumor progression, development of excessive toxicity, withdrawal of consent, or completion of 12 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must have histopathologically-confirmed, supratentorial, glioblastoma.
- Participants must have received first-line treatment regimen consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide.
- Participants must be first recurrence or progression of glioblastoma after first-line treatment regimen.
- Participants must have demonstration of recurrent disease on MRI following prior therapy.
- Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm in one dimension on MRI performed within 14 days prior to first treatment. If receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI.
Key exclusion criteria (5 listed)
- Treatment with any chemotherapy other than temozolomide prior to enrollment.
- Progressive or recurrent glioblastoma documented by MRI earlier than 12 weeks after completion of radiotherapy.
- History of any other cancer.
- HIV infection.
- Women who are pregnant or breast feeding.
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 |
|---|---|---|
| TemozolomideAlso: Temodal | Drug | Arm 2,continuous dose-intense regimen, Arm1 ,one-week on/one-week off regimen |
Primary outcome
Progress-Free Survival at 6 months (PFS6)
Time frame: 6 months
4 secondary outcomes
Overall Survival(OS)
Time frame: 2 years
Progression free survival
Time frame: 2 years
Objective Response Rate
Time frame: up to 52 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
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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.
Junping Zhang, MD principal investigator
Beijing Sanbo Brain Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Glioblastoma, run by Beijing Sanbo Brain Hospital.
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 13 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-Free Survival at 6 months (PFS6) (time frame: 6 months). 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 24 Jul 2023.