Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469937
Status:
TERMINATED
Last Update Posted:
2012-02-28
First Post:
2007-05-03
Brief Title:
Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells Drugs such as lithium may protect normal cells from the side effects of radiation therapy Giving lithium together with radiation therapy may allow a higher dose of radiation therapy to be given so that more tumor cells are killed
PURPOSE This phase I trial is studying the side effects and best dose of lithium when given together with whole-brain radiation therapy in treating patients with brain metastases from primary cancer outside the brain
PURPOSE This phase I trial is studying the side effects and best dose of lithium when given together with whole-brain radiation therapy in treating patients with brain metastases from primary cancer outside the brain
Detailed Description:
OBJECTIVES
Determine the feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance in patients with primary extracranial malignancy and brain metastases
OUTLINE This is an open-label dose-escalation study of lithium carbonate
Patients receive oral lithium carbonate twice daily on days 1-7 and 2-4 times daily on days 8-21 Patients undergo whole-brain radiotherapy once daily on days 8-12 and 15-19
Cohorts of 3-6 patients receive escalating doses of lithium carbonate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Quality of life and mental status are assessed at baseline on days 1 8 and 15 at 1-month post-treatment and then periodically thereafter
After completion of study treatment patients are followed at 1 month and then periodically thereafter
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Determine the feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance in patients with primary extracranial malignancy and brain metastases
OUTLINE This is an open-label dose-escalation study of lithium carbonate
Patients receive oral lithium carbonate twice daily on days 1-7 and 2-4 times daily on days 8-21 Patients undergo whole-brain radiotherapy once daily on days 8-12 and 15-19
Cohorts of 3-6 patients receive escalating doses of lithium carbonate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Quality of life and mental status are assessed at baseline on days 1 8 and 15 at 1-month post-treatment and then periodically thereafter
After completion of study treatment patients are followed at 1 month and then periodically thereafter
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-RAD-0521 | None | None | None |
| VU-IRB-051043 | None | None | None |