Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04668833 - ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter Phase 2
Recruiting NCT05085548 - ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies Phase 1
Completed NCT01924689 - Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies Phase 1
Completed NCT00310895 - Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies Phase 1
Completed NCT01183364 - A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors Phase 1
Terminated NCT01290380 - A Study to Evaluate the Effects of ASA404 Alone or in Combination With Taxane-based Chemotherapies on the Pharmacokinetics of Drugs in Patients With Advanced Solid Tumor Malignancies Phase 1
Terminated NCT01118819 - Safety Study of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies Phase 1