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Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Phase 2 trial testing Temozolomide in Glioblastoma in 127 participants. Completed in 4 May 2017.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 127 |
| Start date | 9 August 2005 |
| Primary completion | 4 May 2017 |
| Estimated completion | 4 May 2017 |
| Sites | 3 locations across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
Adults 18 to 70, any sex, with Glioblastoma or Gliomas. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Metronomic Therapy Cohort | 69 | |
| Dose-Dense Therapy Cohort | 80 |
| Group | Value | 95% CI |
|---|---|---|
| Metronomic Therapy Cohort | 46 | |
| Dose-Dense Therapy Cohort | 56 |
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Metronomic Therapy Cohort | Dose-Dense Therapy Cohort |
|---|---|---|---|
| ALT | Investigations | — | — |
| Platelets | Investigations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hemoglobin | Blood and lymphatic system disorders | — | — |
| Lymphopenia | Investigations | — | — |
| AST | Investigations | — | — |
| Leukocytes | Blood and lymphatic system disorders | — | — |
| Bilirubin | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — |
| ANC | Investigations | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| INR | Investigations | — | — |
| Alkaline Phosphatase | Investigations | — | — |
| PTT | Investigations | — | — |
| Thrombosis | Vascular disorders | — | — |
| Creatinine | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Hypercholesterolemia | Investigations | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Hypertriglyceridemia | Metabolism and nutrition disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Lipase | Investigations | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Blurred vision | Eye disorders | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — |
| Amylase | Investigations | — | — |
| Fatigue | General disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Muscle weakness - right sided | Musculoskeletal and connective tissue disorders | — | — |
| Muscle weakness - Left sided | Musculoskeletal and connective tissue disorders | — | — |
| Muscle weakness extremity - lower | Musculoskeletal and connective tissue disorders | — | — |
| Urinary Frequency | Renal and urinary disorders | — | — |
| Hypomagnesmia | Metabolism and nutrition disorders | — | — |
| Infection | Infections and infestations | — | — |
| Edema: limb | General disorders | — | — |
Data from ClinicalTrials.gov NCT00200161 adverse events section.
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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