Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies|
- 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.
- To define the dose limiting and other toxicities of the combination therapy
- To determine the dosing that should be used in future safety and efficacy (Phase II) trials
- To study retinoic acid receptor expression and histone acetylation status to ascertain biologic effect on peripheral blood mononuclear cells and tissue obtained from selected patients who undergo tumor biopsies.
- To assess for tumor responses to combination therapy.
|Study Start Date:||July 2003|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195156
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||David Nanus, M.D.||Weill Medical College of Cornell University|