TriangleNCT00450814 · OUTCOME
Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
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 weeks
What was measured
The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
Analysis population: Only phase I patients who completed the study are included in this analysis.
Groups in this outcome
Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
| Group | Source count |
|---|---|
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 | 3 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 | 3 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 | 3 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 | 3 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 | 3 |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 | 6 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 | 3 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 | 3 |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 1 (MV-NIS Alone) Dose Level 6 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- units
- Participants
- description
- The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.
- groups
- description
- Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
- id
- OG000
- title
- Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
- description
- Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
- id
- OG001
- title
- Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
- description
- Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
- id
- OG002
- title
- Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
- description
- Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
- id
- OG003
- title
- Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
- description
- Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
- id
- OG004
- title
- Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
- description
- Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
- id
- OG005
- title
- Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
- description
- Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
- id
- OG006
- title
- Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
- description
- Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
- id
- OG007
- title
- Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
- description
- Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
- id
- OG008
- title
- Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Only phase I patients who completed the study are included in this analysis.
- reporting Status
- POSTED
- time Frame
- 6 weeks
- title
- Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice