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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 15, 2013
Last verified: March 2013
History of Changes
  Purpose

  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.


Condition Intervention Phase
Lung Cancer
 Drug: Hydralazine and Valproic Acid
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Protocol of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996060

Locations
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Monte Shaheen, M.D. University of New Mexico Cancer Center
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00996060     History of Changes
Other Study ID Numbers: INST 0712C, NCI-2011-02651
Study First Received: March 26, 2009
Last Updated: March 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico Cancer Care Alliance:
Lung Cancer
Advanced Lung Cancer
Unresectable Lung cancer
Previously treated lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Valproic Acid
Hydralazine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013