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Temozolomide 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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 22, 2008
    Last Updated
    May 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    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

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    Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)

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