Use of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies
The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. A primary endpoint will be to determine any potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen.
- Secondary Objectives:
The secondary endpoint of this study will be to determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Protocol of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies|
- A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To determine any potential anti-tumor effects, as determined by the objective tumor response, clinical benefit, the time to tumor response, the time to tumor progression, and the overall survival. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||August 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Drug: Hydralazine and Valproic Acid
This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996060
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator:||Monte Shaheen, M.D.||University of New Mexico Cancer Center|