Phase 2
N=30
Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)
Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00684567 ↗Enrolled (actual)
30
Serious AEs
43.3%
Results posted
Mar 2009
Primary outcome: Primary: Adverse Events With an Incidence of Greater Than or Equal to 20% — 25; 17; 17; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Radiotherapy (Radiation); Temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events With an Incidence of Greater Than or Equal to 20% |
25; 17; 17; 15; 14; 11 | — |
| PRIMARY Adverse Drug Reactions With an Incidence of Greater Than or Equal to 20% |
15; 11; 6; 6; 6; 7 | — |
| PRIMARY Abnormal Changes in Laboratory Test Values With an Incidence of Greater Than or Equal to 20% |
24; 14; 10 | — |
| SECONDARY Number of Participants With Progression Free Survival (PFS) for 1 Year |
11 | — |
| SECONDARY Number of Participants With a Response (Complete Response [CR] + Partial Response [PR]) in Terms of Overall Tumor Response |
6 | — |
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.
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 =18 and = 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.
Data sourced from ClinicalTrials.gov (NCT00684567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.