Trial Outcomes & Findings for Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma (NCT NCT00462982)
NCT ID: NCT00462982
Last Updated: 2015-12-30
Results Overview
Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, X-ray) or as \>10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.
COMPLETED
PHASE2
8 participants
up to a year
2015-12-30
Participant Flow
Participant milestones
| Measure |
Sunitinib
Patients will be treated with 50 mg daily for four out of every six weeks.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Sunitinib
Patients will be treated with 50 mg daily for four out of every six weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Patient Not Treated
|
2
|
Baseline Characteristics
Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
Baseline characteristics by cohort
| Measure |
Sunitinib
n=8 Participants
Patients will be treated with 50 mg daily for four out of every six weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to a yearResponse and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques (CT, MRI, X-ray) or as \>10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.
Outcome measures
| Measure |
Sunitinib
n=5 Participants
Patients will be treated with 50 mg daily for four out of every six weeks.
|
|---|---|
|
Central Nervous System (CNS) Response Rate by RECIST Criteria
Stable Disease (SD)
|
3 participants
|
|
Central Nervous System (CNS) Response Rate by RECIST Criteria
Progression of Disease (POD)
|
2 participants
|
Adverse Events
Sunitinib
Serious adverse events
| Measure |
Sunitinib
n=8 participants at risk
Patients will be treated with 50 mg daily for four out of every six weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
AST, SGOT
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pain - Head/headache
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Speech impairment
|
12.5%
1/8 • Number of events 1
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
25.0%
2/8 • Number of events 2
|
Other adverse events
| Measure |
Sunitinib
n=8 participants at risk
Patients will be treated with 50 mg daily for four out of every six weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
AST, SGOT
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
25.0%
2/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
37.5%
3/8 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Neuropathy: sensory
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
25.0%
2/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
12.5%
1/8 • Number of events 1
|
Additional Information
Dr. Robert Motzer
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place