A Phase 2 interventional study of Bevacizumab and Metronomic Temozolomide in Glioblastoma Multiforme, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-27.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.
This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of 10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.
Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin against malignant glioma, it is reasonable to study the combination in recurrent malignant glioma patients.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 32 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
Patients will receive up to 12 cycles of bevacizumab (Avastin) and metronomic temozolomide (Temodar), and each cycle is 28 days. Bevacizumab will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
Drug: Bevacizumab · Drug: Metronomic Temozolomide
Bevacizumab administered intravenously 10mg/kg every other week.
Also known as: Avastin
Temozolomide 50mg/m2 given orally on a daily basis.
Also known as: Temodar
6-Month Progression-free Survival
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. \[Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).\]
Time frame: 6 months
Response Rate
The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
Time frame: 27 months
Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage
Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage
Time frame: 27 months
Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity
Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity
Time frame: 27 months
| Milestone | Bevacizumab and Temozolomide |
|---|---|
| Started | 32 |
| Completed | 32 |
| Not completed | 0 |
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. \[Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).\]
| percentage of participants | Bevacizumab and Metronomic Temozolomide |
|---|---|
| 6-Month Progression-free Survival | 18.8 (7.6 to 33.7) |
The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
| Number of participants | Bevacizumab and Metronomic Temozolomide |
|---|---|
| Response Rate | 9 |
Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage
| participants | Bevacizumab and Metronomic Temozolomide |
|---|---|
| CNS Hemorrhage | 0 |
| Systemic Hemorrhage | 0 |
Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity
| participants | Bevacizumab and Metromonic Temozolomide |
|---|---|
| Grade ≥ 4 hematologic toxicities | 0 |
| Grade ≥ 3 non-hematologic toxicities | 14 |
Collected over 27 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab and Temozolomide | — | 8/32 (25%) | 15/32 (46.9%) |
| Event | Bevacizumab and Temozolomide |
|---|---|
| Death NOSGeneral disorders | 3/32 |
| ColitisGastrointestinal disorders | 1/32 |
| DiarrheaGastrointestinal disorders | 1/32 |
| HemorrhoidsGastrointestinal disorders | 1/32 |
| PancreatitisGastrointestinal disorders | 1/32 |
| Lung infectionInfections and infestations | 1/32 |
| DehydrationMetabolism and nutrition disorders | 1/32 |
| HyperglycemiaMetabolism and nutrition disorders | 1/32 |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 1/32 |
| Cognitive disturbanceNervous system disorders | 1/32 |
| Event | Bevacizumab and Temozolomide |
|---|---|
| Blurred visionEye disorders | 6/32 |
| FatigueGeneral disorders | 6/32 |
| Memory impairmentNervous system disorders | 6/32 |
| Peripheral motor neuropathyNervous system disorders | 6/32 |
| AtaxiaNervous system disorders | 5/32 |
| Depressed level of consciousnessNervous system disorders | 4/32 |
| NauseaGastrointestinal disorders | 3/32 |
| DysphasiaNervous system disorders | 3/32 |
| ConfusionPsychiatric disorders | 3/32 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/32 |
| Age Continuous(years) | Bevacizumab and Temozolomide |
|---|---|
| Mean | 54.4 ± 12.8 |
| Sex: Female, Male(Participants) | Bevacizumab and Temozolomide |
|---|---|
| Female | 13 |
| Male | 19 |
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