Status:
COMPLETED
Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 adva...
Detailed Description
This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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:
- Absolute neutrophil count greater than 1000/µL
- Platelet count greater than 100'000/µL
- Renal function:
- a. Serum creatinine less than 2.0 mg %
- Hepatic function:
- Bilirubin less than 1.5x normal
- Serum calcium less than 12 mg/dl
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00996060
Start Date
July 1 2008
End Date
January 1 2013
Last Update
January 18 2016
Active Locations (1)
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1
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106