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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00513162 |
Purpose
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroectodermal Tumor Brain Metastases Advanced Cancer |
Drug: Valproate Drug: Etoposide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Valproate (Valproic Acid) and Etoposide for Patients With Progressive, Relapsed or Refractory Neuronal Tumors and Brain Metastases |
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2007 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Valproate + Etoposide: Experimental |
Drug: Valproate
Starting Dose of 10 mg/kg By Mouth Daily
Drug: Etoposide
25 - 50 mg/m^2 By Mouth Daily
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Johannes Wolff, MD | 713-794-4963 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Johannes Wolff, MD | |
| Principal Investigator: | Johannes Wolff, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Johannes Wolff, MD/Professor ) |
| Study ID Numbers: | 2007-0370 |
| Study First Received: | August 7, 2007 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00513162 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Advanced Cancers Brain CNS Neural Pediatrics Spinal Neuroectodermal Tumor |
Brain Metastases Valproate Valproic Acid Depakene Etoposide VePesid |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Neoplasms Brain Diseases Valproic Acid Etoposide phosphate Neoplastic Processes Neoplasms by Site Pathologic Processes Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Neoplasm Metastasis Etoposide Nervous System Neoplasms Neoplasms by Histologic Type Tranquilizing Agents Nervous System Diseases Central Nervous System Diseases Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Brain Neoplasms Neuroectodermal Tumors Neoplasms GABA Agents |