NCT00445965 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 78
- units
- Participants
- groups
- description
- This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-3F8: Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
- id
- BG000
- title
- 131I-3F8
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 1
- upper Limit
- 63
- value
- 10
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 34
- title
- Female
- measurements
- group Id
- BG000
- value
- 44
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 71
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 4
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 8
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 63
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 78
- title
- United States
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 78
- units
- Participants
- groups
- description
- This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease. DNA analysis immunologic technique pharmacological study iodine I 131 monoclonal antibody 3F8 131I-3F8: Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.
- id
- BG000
- title
- 131I-3F8
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 1
- upper Limit
- 63
- value
- 10
- dispersion Type
- FULL_RANGE
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 34
- title
- Female
- measurements
- group Id
- BG000
- value
- 44
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 71
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 4
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 8
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 63
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 78
- title
- United States
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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