A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Progression Free Survival (PFS) at 6 Months Utilizing McDonald Criteria for Response, Progression and Relapse
Complete Response: Disappearance of all lesions, disease signs and symptoms related to the tumor. Partial Response (PR): When compared with pretreatment measurements, a reduction of 50% decrease in the sum of the longest diameters of all target enhancing lesions, taking as reference the baseline sum of the longest diameter. Stable Disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started. Objective Progression or Relapse: Relative to pretreatment measurements, an increase in the sum of the diameters of any measured enhancing lesion by at least 25% increase in the sum of the longest diameters since the treatment started or the appearance of new enhancing lesions.
6 Months
No
Edward Pan, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
MCC-14916
NCT00606008
March 2007
August 2012
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |