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Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00530907 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Advanced Cancer |
Drug: Valproic Acid Drug: Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Valproic Acid Given in Combination With Bevacizumab in Patients With Advanced Cancer to Determine Safety and Tolerability |
Estimated Enrollment: | 48 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Valproic Acid + Bevacizumab
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Drug: Valproic Acid
10 mg/kg PO daily x 28 days
Drug: Bevacizumab
2.5 mg/kg IV over 90 minutes every 2 weeks
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Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels. Valproic acid works the same was way as bevacizumab and is also used in the treatment of seizures, migraine headaches, and mood disturbances in bipolar disorders.
Before you can start receiving the study drugs, you will have screening tests. These tests will help the study doctor decide if you are eligible to take part in this study.
If you are found to be eligible to take part in this study, you will receive the study drugs as an outpatient.
This is an investigational study. Bevacizumab and valproic acid are both FDA approved and commercially available. Their use together in this study is investigational and authorized for use in research only. Up to 48 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contact: Siqing Fu, MD, PhD | 713-792-9669 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Siqing Fu, MD, PhD |
Principal Investigator: | Siqing Fu, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Siqing Fu, MD, PhD/Assistant Professor ) |
Study ID Numbers: | 2005-0676 |
Study First Received: | September 14, 2007 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00530907 |
Health Authority: | United States: Institutional Review Board |
Advanced Cancer Valproic Acid Bevacizumab Avastin |
Bevacizumab Valproic Acid |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses GABA Agents Growth Inhibitors Angiogenesis Modulating Agents Central Nervous System Agents Anticonvulsants |