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
2 other identifiers
interventional
29
1 country
1
Brief Summary
- 1.Primary Objective:
- 2.Secondary Objectives:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 lung-cancer
Started Jul 2008
Typical duration for phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 18, 2016
January 1, 2016
4.4 years
March 26, 2009
January 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen.
28 days
Secondary Outcomes (1)
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.
28 days
Study Arms (1)
Hydralazine and Valproic Acid
EXPERIMENTALStarting dose of Hydralazine is 25 mg orally daily, days 1-28. (See Intervention for Dose Escalation Schema) Valproic acid 250 mg orally three times per day for days -14 through -8, then 500 mg orally three times per day daily for days -7 through 28, with the dose titrated to keep the serum level between 0.4 and 0.7 mM.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- All patients with lung cancer who have disease which has been previously treated and/or for which there is no acceptable standard treatment regimen available, and cannot be treated definitively with either surgery or radiotherapy.
- All will be appropriate candidates for treatment, and are not candidates for treatment with protocols of higher priority.
- All patients should have an ECOG/Zubrod/SWOG performance status of less than 2 at the time of the initiation of therapy
- Adequate end-organ function
- No severe comorbid disease
- Ability to provide informed consent.
- Signed Informed Consent
- ECOG/Zubrod/SWOG Performance Status less than 2
- Life expectancy greater than 8 weeks
- Male or female' age greater than 18 years
- Patients of childbearing potential must be using an effective means of contraception.
- Histologic diagnosis of lung cancer that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease, and for which there is no standard chemotherapeutic option remaining or available
- All participants must have either previously received or refused standard chemotherapy
- Baseline laboratory values (bone marrow, renal, hepatic):
- Adequate bone marrow function:
- +7 more criteria
You may not qualify if:
- Pregnant or lactating females
- Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
- Uncontrolled' clinically significant dysrhythmia
- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- Prior autoimmune disease
- Uncontrolled metastatic disease of the central nervous system
- Radiotherapy within the 2 weeks before Cycle 1' Day -14
- Surgery within the 2 weeks before Cycle 1' Day -14
- Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monte Shaheen, M.D.
University of New Mexico Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
October 16, 2009
Study Start
July 1, 2008
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
January 18, 2016
Record last verified: 2016-01