RTA 744 Injection in Patients With Leptomeningeal Disease
|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|
|Primary Completion Date :||March 2010|
|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 ]
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|