NCT00996060

Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies

A Phase 1 Protocol of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. Primary Objective: 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. 2. 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.

Detailed description

This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Hydralazine and Valproic Acid: Cohort -1	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. In this cohort, Hydralazine is administered at 10 mg/day.
DRUG	Hydralazine and Valproic Acid: Cohort 0	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 25 mg/day in this cohort.
DRUG	Hydralazine and Valproic Acid: Cohort 1	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 50 mg/day in this cohort.
DRUG	Hydralazine and Valproic Acid: Cohort 2	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 100 mg/day in this cohort as 25 mg four times per day.
DRUG	Hydralazine and Valproic Acid: Cohort 3	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 200 mg/day in this cohort as 50 mg four times per day.
DRUG	Hydralazine and Valproic Acid: Cohort 4	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 300 mg/day in this cohort as 75 mg four times per day.
DRUG	Hydralazine and Valproic Acid: Cohort 5	Initially, 3 patients will be enrolled into each cohort, beginning with the hydralazine 25 mg PO daily, with the valproic acid dosing beginning two weeks earlier to achieve a steady state level of valproic acid in the blood. Hydralazine is administered at 400 mg/day in this cohort as 100 mg four times per day.

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2009-10-16
• Last updated: 2016-01-18

Locations

1 site across 1 country: United States