Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies

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

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