Back to resultsTemozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
Primary Purpose
Glioblastoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiotherapy
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00684567
Brief Title
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
Official Title
SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 27, 2005 (Actual)
Primary Completion Date
October 31, 2007 (Actual)
Study Completion Date
October 31, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. Progression free survival and response rate will also be calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Irradiation, radiation therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodal, Temodar, SCH 052365
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events With an Incidence of Greater Than or Equal to 20%
Description
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.
Time Frame
until 30 days after the completion of administration of monotherapy
Title
Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20%
Description
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Time Frame
until 30 days after the completion of administration of monotherapy
Title
Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20%
Description
Safety was assessed from the start of administration during the concomitant radiotherapy phase until 30 days after the completion of administration of monotherapy.
Time Frame
until 30 days after the completion of administration of monotherapy
Secondary Outcome Measure Information:
Title
Number of Participants With Progression Free Survival (PFS) for 1 Year
Description
Administration of SCH 52365 was continued until progression was observed (progression was judged by the investigator based on MRI and clinical symptoms).
Time Frame
1 year after the start of admininstration in the concomitant radiotherapy phase
Title
Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response
Description
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.
Time Frame
1 year after the start of administration in the concomitant radiotherapy phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
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