NCT00195156

Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies

Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	ATRA-IV
DRUG	Depakote

Timeline

• Start date: 2003-07-01
• First posted: 2005-09-19
• Last updated: 2006-09-14

Locations

1 site across 1 country: United States