Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195156
Status:
TERMINATED
Last Update Posted:
2006-09-14
First Post:
2005-09-14
Brief Title:
Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out the highest tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid ATRA-IV in patients with advanced solid tumor malignancies
Detailed Description:
To determine the maximum tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid ATRA-IV in patients with advanced solid tumor malignancies
This will be a 2-step dose escalation study Once the patient starts therapy at a designated dose level it will not be escalated for that patient Three patients at each dose level must complete 4 weeks of therapy before escalating to the next higher level If none of the patients experience dose limiting toxicity DLT then 3 new patients will be treated with the next higher dose level
This will be a 2-step dose escalation study Once the patient starts therapy at a designated dose level it will not be escalated for that patient Three patients at each dose level must complete 4 weeks of therapy before escalating to the next higher level If none of the patients experience dose limiting toxicity DLT then 3 new patients will be treated with the next higher dose level
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