Use of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00996060
First received: March 26, 2009
Last updated: March 20, 2014
Last verified: March 2014

March 26, 2009
March 20, 2014
July 2008
December 2012   (final data collection date for primary outcome measure)
A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00996060 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Use of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies
A Phase 1 Protocol of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies
  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 advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. A primary endpoint will be to determine any potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen.

  2. Secondary Objectives:

The secondary endpoint of this study will be to determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: Hydralazine and Valproic Acid
Hydralazine 25 mg PO daily, days 1-28 Valproic acid 250 mg PO TID for days -14 through -8, then 500 mg PO TID daily for days -7 through 28, with the dose titrated to keep the serum level between 0.4 and 0.7 mM.
Other Name: Depakote
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
August 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00996060
INST 0712C, NCI-2011-02651
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Monte Shaheen, M.D. University of New Mexico Cancer Center
New Mexico Cancer Care Alliance
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP