RTA 744 Injection in Patients With Leptomeningeal Disease
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|ClinicalTrials.gov Identifier: NCT00512460|
Recruitment Status : Terminated (Study was closed due to loss of industry sponsorship)
First Posted : August 7, 2007
Last Update Posted : May 16, 2016
The primary objectives of this study are:
- To determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor.
- In a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose (MTD), to characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF.
The secondary objectives of this study are:
- To document any potential antitumor activity of RTA 744 in this patient population.
- To correlate pharmacokinetic information with clinical (efficacy and safety) responses, as a possible help in selecting appropriate doses for later studies.
|Condition or disease||Intervention/treatment||Phase|
|Neoplastic Meningitis Solid Tumor Lymphoma Leukemia Brain Tumor||Drug: RTA 744||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Safety and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent, Progressive or Refractory Neoplastic Meningitis|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
|Experimental: RTA 744||
Drug: RTA 744
4.8 mg/m^2 by vein Over 2 Hours On Days 1-3.
- To study the highest tolerable dose of RTA 744 that can be given to patients with cancer that has spread to the meninges of the brain or the spine. [ Time Frame: 3 Years ]
- To study the level of effectiveness of RTA 744 on the disease. [ Time Frame: 3 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512460
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Morris D. Groves, MD||M.D. Anderson Cancer Center|