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

Inclusion Criteria

ELIGIBILITY:

1. 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.

2. All will be appropriate candidates for treatment, and are not candidates for
treatment with protocols of higher priority.

3. All patients should have an ECOG/Zubrod/SWOG performance status of less than less
than 2 at the time of the initiation of therapy

4. Adequate end-organ function

5. No severe comorbid disease

6. Ability to provide informed consent.

7. Signed Informed Consent

8. ECOG/Zubrod/SWOG Performance Status less than 2

9. Life expectancy greater than 8 weeks

10. Male or female' age greater than 18 years

11. Patients of childbearing potential must be using an effective means of contraception.

12. 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

13. All participants must have either previously received or refused standard
chemotherapy

14. Baseline laboratory values (bone marrow, renal, hepatic):

Adequate bone marrow function:

1. Absolute neutrophil count greater than 1000/µL

2. Platelet count greater than 100'000/µL

Renal function:

a. Serum creatinine less than 2.0 mg %

Hepatic function:

1. Bilirubin less than 1.5x normal

2. Serum calcium less than 12 mg/dl

Exclusion Criteria

1. Pregnant or lactating females

2. Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0

3. Uncontrolled' clinically significant dysrhythmia

4. Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
growth in that lesion

5. Prior autoimmune disease

6. Uncontrolled metastatic disease of the central nervous system

7. Radiotherapy within the 2 weeks before Cycle 1' Day -14

8. Surgery within the 2 weeks before Cycle 1' Day -14

9. Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications