GlioblastomaPhase 2NCT00684567
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
A Phase 2 study testing Radiotherapy and Temozolomide in people with Glioblastoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Radiotherapy and Temozolomide
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2005to 31 Oct 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade IV.
- Histological diagnosis must be made locally after biopsy or neurosurgical tumor resection.
- Four or more unstained tissue sections or a paraffin block must be provided to the Pathological Judgment Committee as tissue specimens.
- Initial surgery/biopsy at diagnosis performed <=6 weeks (42 days) prior to treatment with temozolomide.
- Age: >=18 and <=70 years.
- ECOG performance status <=2.
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- Stable, non-increasing dose of corticosteroids over the 14 days prior to treatment with temozolomide.
- No prior chemotherapy or radiotherapy.
- Laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria:
- absolute neutrophil count >= 1500/mm^3;
- platelet count >= 100,000/mm^3;
- serum creatinine <=1.5 times the upper limit of laboratory normal;
- total bilirubin <=1.5 times the upper limit of laboratory normal;
- glutamic oxaloacetic transaminase or glutamic pyruvic transaminase <2.5 times the upper limit of laboratory normal;
- alkaline phosphatase < 2.5 times the upper limit of laboratory normal.
- Absence of pathological conditions that interfere with taking oral drugs.
- Contraception during the study period (from informed consent to the day of the last observation/examination of this study) is required in sexually active, potentially fertile patients, regardless of sex, under the supervision of the investigator or sub-investigator.
- The investigator and/or subinvestigator must judge that life expectancy is 12 weeks or more.
- Patients may be included regardless of sex or inpatient/outpatient.
Who cannot join
- Extensively disseminated glioblastoma multiforme.
- Severe disorders in the heart, liver, kidney, blood, etc.
- Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer.
- Women who are pregnant or lactating.
- Women who may be pregnant or who could become pregnant and do not adopt contraception method(s).
- Participation in another clinical study within 6 weeks prior to the initiation of administration of temozolomide.
- Subjects who the investigator and/or subinvestigator judged inappropriate to participate in the study.
About this study
Official title: SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme
The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.
- Conditions
- Glioblastoma
- Being tested
- Radiotherapy, Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Irradiation, radiation therapy
Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.
TemozolomideDrug
Also called Temodal, Temodar, SCH 052365
During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy. Receives: Radiation: Radiotherapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events With an Incidence of Greater Than or Equal to 20%
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.
Measured: until 30 days after the completion of administration of monotherapy
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Measured: until 30 days after the completion of administration of monotherapy
Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Measured: until 30 days after the completion of administration of monotherapy
Secondary outcomes (2)
Number of Participants With Progression Free Survival (PFS) for 1 Year
Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).
Measured: 1 year after the start of admininstration in the concomitant radiotherapy phase
Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response
CR = measurable lesion disappeared.
PR = total sum of lesions measurable in bidimension decreased by 50% or more on whole and no secondary progression attributable to tumor was noted. No onset of new lesion.
Measured: 1 year after the start of administration in the concomitant radiotherapy phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study start27 Sep 2005
- Primary completion31 Oct 2007
- Study completion31 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684567
- Sponsor's protocol ID
- P04661
- Other IDs
- JPC-05-351-22
- Status last verified
- May 2017
- First submitted
- 22 May 2008
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00684567
- Acronym / sponsor ID
- P04661
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2005 (actual)
- Primary completion
- 31 Oct 2007 (actual)
- Study completion
- 31 Oct 2007 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 12 Mar 2009
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 safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: Radiotherapy, Drug: TemozolomideIt is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histopathologically confirmed newly diagnosed glioblastoma multiforme with WHO grade IV.
- Histological diagnosis must be made locally after biopsy or neurosurgical tumor resection.
- Four or more unstained tissue sections or a paraffin block must be provided to the Pathological Judgment Committee as tissue specimens.
- Initial surgery/biopsy at diagnosis performed <=6 weeks (42 days) prior to treatment with temozolomide.
- Age: >=18 and <=70 years.
Key exclusion criteria (7 listed)
- Extensively disseminated glioblastoma multiforme.
- Severe disorders in the heart, liver, kidney, blood, etc.
- Presence of previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non melanoma skin cancer.
- Women who are pregnant or lactating.
- Women who may be pregnant or who could become pregnant and do not adopt contraception method(s).
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 |
|---|---|---|
| RadiotherapyAlso: Irradiation, radiation therapyRadiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher. | Radiation | Single arm |
| TemozolomideAlso: Temodal, Temodar, SCH 052365During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose. | Drug | Single arm |
Primary outcome
Adverse Events With an Incidence of Greater Than or Equal to 20%
Time frame: until 30 days after the completion of administration of monotherapy
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy. Adverse events were classified under the system organ class using MedDRA-J Version 11.0.
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
Time frame: until 30 days after the completion of administration of monotherapy
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
Time frame: until 30 days after the completion of administration of monotherapy
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
2 secondary outcomes
Number of Participants With Progression Free Survival (PFS) for 1 Year
Time frame: 1 year after the start of admininstration in the concomitant radiotherapy phase
Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response
Time frame: 1 year after the start of administration in the concomitant radiotherapy phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy and Temozolomide in people with Glioblastoma, run by Merck Sharp & Dohme LLC.
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 19 inclusion and 7 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 7 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events With an Incidence of Greater Than or Equal to 20% (time frame: until 30 days after the completion of administration of monotherapy). The study lists 3 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 7 Jun 2017.