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

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase 1 Protocol of Hydralzaine 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


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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Monte Shaheen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Food and Drug Administration

Study ID:

INST 0712C



Start Date:

July 2008

Completion Date:

August 2014

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Advanced Lung Cancer
  • Unresectable Lung cancer
  • Previously treated lung cancer
  • Lung Neoplasms



University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636