Last reviewed · How we verify
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Phase 2 trial testing radiotherapy (RT) in combination with temozolomide and bevacizumab in Brain Cancer in 40 participants. Completed in 23 March 2017.
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 28 October 2008 |
| Primary completion | 23 March 2017 |
| Estimated completion | 23 March 2017 |
| Sites | 3 locations across United States |
Memorial Sloan Kettering Cancer Center — full company profile →
18 and older, any sex, with Brain Cancer or Malignant Glioma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
| Group | Value | 95% CI |
|---|---|---|
| RT, With Temozolomide and Bevacizumab | 40 |
| Group | Value | 95% CI |
|---|---|---|
| RT, With Temozolomide and Bevacizumab | 10 | 8 – 11 |
| Group | Value | 95% CI |
|---|---|---|
| RT, With Temozolomide and Bevacizumab | 37 | |
| RT, With Temozolomide and Bevacizumab | 3 |
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 | RT, With Temozolomide and … |
|---|---|---|
| Seizure | Nervous system disorders | — |
| Platelets | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Thrombosis/thrombus/embolism | Vascular disorders | — |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Creatinine | Investigations | — |
| Infection, other | Infections and infestations | — |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | — |
| Pain - Head/headache | Nervous system disorders | — |
| Pyramidal tract dysfunction | Nervous system disorders | — |
| Speech impairment | Nervous system disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Confusion | Psychiatric disorders | — |
| Glomerular filtration rate | Renal and urinary disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Hemorrhage, CNS | Nervous system disorders | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — |
| Muscle weakness - Left-sided | Musculoskeletal and connective tissue disorders | — |
| Ocular/Visual - Other (specify) | Eye disorders | — |
| Pain - Abdomen NOS | Gastrointestinal disorders | — |
| Pain - Back | Musculoskeletal and connective tissue disorders | — |
| Personality/behavioral | Psychiatric disorders | — |
| Vasovagal episode | Nervous system disorders | — |
| Reaction | System | RT, With Temozolomide and … |
|---|---|---|
| Fatigue | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hemorrhage/Bleeding - other | Injury, poisoning and procedural complications | — |
| Hypertension | Vascular disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Leukocytes (total WBC) | Investigations | — |
| Neuropathy - sensory | Nervous system disorders | — |
| Pain - Joint | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Hemorrhage, Nose | Respiratory, thoracic and mediastinal disorders | — |
| Hemorrhage, Oral cavity | Gastrointestinal disorders | — |
| Memory Impairment | Nervous system disorders | — |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | — |
| Pain - neck | Musculoskeletal and connective tissue disorders | — |
| Platelets | Investigations | — |
| Proteinuria | Renal and urinary disorders | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
| Seizure | Nervous system disorders | — |
| Thrombosis/thrombus/embolism | Vascular disorders | — |
| Urinary frequency/urgency | Renal and urinary disorders | — |
| Vision-blurred vision | Eye disorders | — |
| Wound complication, non-infectious | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Seizure, Platelets, Nausea, Thrombosis/thrombus/embolism, Thrombotic microangiopathy, Vomiting, Creatinine, Infection, other.
Data from ClinicalTrials.gov NCT00782756 adverse events section.
The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.
6 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00782756.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing