Glioblastoma Clinical Trial
Official title:
A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
We are asked patients to take part in this study because they had recurrent (returned) (1st
or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).
The purposes of this study are:
- To see if Sutent has any change on the patient and their cancer.
- To see if Sutent will slow or stop the growth of their tumor.
- To measure the safety of Sutent. Sutent is Food and Drug Administration (FDA) approved
to treat patients with a gastrointestinal stromal tumor after the disease worsened
while taking another medicine called imatinib mesylate or when imatinib mesylate cannot
be taken. Sutent is also FDA approved to treat patients with advanced renal cell
carcinoma. At this time, it is not known whether Sutent will improve symptoms, or help
patients with this disease live longer.
Trial patients received sunitinib 50 mg daily for 4 weeks without regard to meals, followed
by a 2-week rest period. This 6-week regimen constituted 1 cycle. Patients were treated for
up to 9 cycles [~ year) or until disease progression or death or if persistent toxicities
occurred. Complete blood count with differential, complete metabolic profile, neurologic
exam, and brain magnetic resonance imaging (MRI) with contrast were obtained after each
cycle. Toxicity assessments were obtained after each cycle. Toxicity was graded according to
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),
version 3.0.
SCHEDULE OF EVENTS - PROTOCOL ACTIVITIES
<14 Days Prior to Initial Study Treatment:
- Neurological/Oncological History
- Neurological Examination
- Height/Weight/Body Surface Area
- Performance Status
- Quality of Life (QOL) FACT-L
- Laboratory Studies; complete blood count (CBC), Differential, Platelets, prothrombin
time/partial thromboplastin time (PT/PTT), international normalized ratio (INR), Serum
Creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), aspartate
aminotransferase (AST), lactate dehydrogenase (LDH), Total Bilirubin, alkaline
phosphatase (AlkPHs), Pregnancy Test, electrocardiogram (EKG)
- Cranial MRI or CT with and without contrast
- Multiple uptake gated acquisition (MUGA) Scan
Day 1, At the Beginning of Each Treatment Cycle:
- Adverse Event Assessment
- Laboratory Studies; CBC, Differential, Platelets
Every Cycle, Days 42-45 (within 3 days of next scheduled Sutent treatment):
- Neurological/Oncological History
- Neurological Examination
- Height/Weight/Body Surface Area
- Performance Status
- QOL FACT-L
- Laboratory Studies; Serum Creatinine, BUN, ALT, AST, LDH, Total Bilirubin, AlkPHs
- Cranial MRI or CT with and without contrast
- Survival
At Off Study:
- Performance Status
- Cranial MRI or CT with and without contrast
- Survival
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05664243 -
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT02768389 -
Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma
|
Early Phase 1 | |
Recruiting |
NCT05635734 -
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT03679754 -
Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102
|
Phase 1 | |
Completed |
NCT01250470 -
Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma
|
Phase 1 | |
Terminated |
NCT03927222 -
Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma
|
Phase 2 | |
Recruiting |
NCT03897491 -
PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03587038 -
OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma
|
Phase 1 | |
Completed |
NCT01922076 -
Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
|
Phase 1 | |
Recruiting |
NCT04391062 -
Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT03661723 -
Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma
|
Phase 2 | |
Active, not recruiting |
NCT02655601 -
Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001
|
Phase 2 | |
Completed |
NCT02206230 -
Trial of Hypofractionated Radiation Therapy for Glioblastoma
|
Phase 2 | |
Completed |
NCT03493932 -
Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade
|
Phase 1 | |
Terminated |
NCT02709889 -
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
Completed |
NCT03018288 -
Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Not yet recruiting |
NCT04552977 -
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
|
Phase 2 | |
Withdrawn |
NCT02876003 -
Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma
|
Phase 2 |