Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT00195156
Status:
TERMINATED
Last Update Posted:
2006-09-14
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies
Sponsor:
Weill Medical College of Cornell University
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: