Anaplastic Oligoastrocytoma, Anaplastic Oligodendroglioma
Conditions
Keywords
Temozolomide
Brief summary
The purpose of this study is to determine the efficacy and safety of temozolomide in patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma.
Detailed description
Patient with relapsed or advanced anaplastic oligodendroglioma and anaplastic oligoastrocytoma will be enrolled. Enrolled patients will begin on temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle). Patients who were previously treated with any chemotherapy initially received temozolomide 150 mg/m2/d for 5 days (750 mg/m2 per cycle).Patients will be receving a total 6 cycles of chemotheray (4weeks/cycle \* 6cycles = 24weeks). If the patients shows responses to Temozolomide, treatment can be continued by the investigator's discretion. During the administration of Temozolomide, vital signs, physical examination, ECOG performance status, height, weight, hematology and chemistry test, adverse events and concomitant drugs will be evaluated every four weeks. Brain MRI for tumor assessment will be performed once every 12 weeks.
Interventions
DRUGTemozolomide
Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven anaplastic oligodendroglioma or oligoastrocytoma * Progressed or relapsed after surgery or radiation therapy * Female or male aged 20 years or over * At least 1 measurable mass lesion * ECOG performance status 0-3 * Adequate organ function * absolute neutrophil count \> 1,500/μL * platelet count \> 75,000/μL * hemoglobin greater than 9 g/dL or 900g/L * serum creatinine less than 1.5 times the upper limit of laboratory normal * total serum bilirubin less than 1.5 times the upper limit of laboratory normal * AST or ALT less than three times the upper limit of laboratory normal
Exclusion criteria
* Prior course of temozolomide * Combined glioblastoma * Pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 6 month | PFS will be examined with Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 1 year | ORR will be evaluated through the frequency analysis with 95% confidence interval. |
| Overall survival (OS) | 1 years | OS will be examined with Kaplan-Meier method. |
| progression-free survival (PFS) | 1 year | PFS will be examined with Kaplan-Meier method. |
| Number of Participants with Adverse Events | 1 years | Regarding safety endpoints, all adverse events will be individually graded based on the CTCAE version 4.03. The number of participants with adverse events will be summarized using descriptive statistics. |
Other
| Measure | Time frame |
|---|---|
| Predictive biomarker study | 1 year |
Countries
South Korea
Outcome results
None listed