NCT00445965 · OUTCOME
Six-month Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 6 months
Groups in this outcome
131I-3F8
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.
| Group | Source count |
|---|---|
| 131I-3F8 | 78 |
Reported measurements
Source class 1
Participants still alive at the 6-month mark
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 131I-3F8 | 67 | Not reported | Not reported | Not reported | Not reported |
Participants not alive at the 6-month mark
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 131I-3F8 | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 67
- title
- Participants still alive at the 6-month mark
- measurements
- group Id
- OG000
- value
- 11
- title
- Participants not alive at the 6-month mark
- denoms
- counts
- group Id
- OG000
- 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
- OG000
- title
- 131I-3F8
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Six-month Overall Survival
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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