Astrocytoma, Brain Tumor, Recurrent, Glioblastoma, Oligodendroglioma
Conditions
Keywords
Temozolomide, Brain Tumor, Recurrent, Chemotherapy
Brief summary
The purpose of this study is to evaluate the efficacy of temozolomide on a protracted schedule, after standard 5-day temozolomide regimen in patients with recurrent or progressive high grade glioma.
Interventions
DRUGTemozolomide
100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity
Sponsors
Schering-Plough
Marmara University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age \>18 years old * Histopathological diagnosis of high grade glioma (anaplastic astrocytoma or anaplastic oligodendroglioma or anaplastic oligoastrocytoma or glioblastoma multiforme) * Progression after standard dose (D1-5/28 days)temozolomide either during recurrence or adjuvant treatment approved in Magnetic Resonance imaging * Karnofsky Performance Status scale \>/=50 (due to brain pathology) * Adequate hematological, renal and hepatic function * Patients willing to participate in the study and signing the informed consent
Exclusion criteria
* Karnofsky Performance Status scale \<50 * Female patients with pregnancy or with suspicion of pregnancy. Patients with fertility will be warned for appropriate contraception during the study * Patients not suitable for follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival at 6-months | Until progression |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose-Dense Temozolomide Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.
Number of cycles: Until progression or unacceptable toxicity | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Dose-Dense Temozolomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age Continuous | 50 years STANDARD_DEVIATION 14 |
| Region of Enrollment Turkey | 25 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Progression-free Survival at 6-months
Time frame: Until progression
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Temozolomide | Progression-free Survival at 6-months | 17.3 percentage of participants |