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

Solid Tumor Malignancies Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00195156
Study type Interventional
Source Weill Medical College of Cornell University
Contact
Status Terminated
Phase Phase 1
Start date July 2003
View Details
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