A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic Meningitis (LMD)
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|ClinicalTrials.gov Identifier: NCT00527410|
Recruitment Status : Terminated (Business Decision)
First Posted : September 10, 2007
Last Update Posted : November 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Leptomeningeal Carcinomatosis||Drug: RTA 744||Phase 1|
Neoplastic meningitis refers to the deposition of malignant cells in the lining (leptomeninges) of the brain and spine. Neoplastic meningitis from solid tumors most often occurs in patients with advanced systemic disease who have failed prior chemotherapy; it is also frequent in patients with CNS parenchymal metastasis. Patient survival remains low, and better treatments are needed to penetrate the blood brain barrier and treat the entire neuraxis.
RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin. Unlike doxorubicin, RTA 744 has shown ability to cross the blood brain barrier and to achieve high concentration in CNS tumor tissue in animal models. Dose escalation will continue as pre-determined until first occurrence of a dose-limiting toxicity. Maximum tolerated dose will be determined as defined in protocol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 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 :||October 2006|
|Actual Primary Completion Date :||December 2008|
Experimental: RTA 744
RTA 744 injection administered intravenously for a maximum of 18 cycles (54 weeks). Dose escalation based on four dose levels and occurance of dose limiting toxicity (DLT).
Drug: RTA 744
Aqueous solution of RTA 744 is packaged in 5 ml vials - 1 mg/ ml. The drug is mixed in D10W and infused over 2 hours on three consecutive days.
- Determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor. [ Time Frame: evaluation at end of cycle 1 for each cohort ]
- Characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF in a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose (MTD). [ Time Frame: end of study ]
- Document any potential antitumor activity. [ Time Frame: after every even numbered treatment cycle ]
- Correlate pharmacokinetic information with clinical (efficacy and safety) responses. [ Time Frame: end of study ]
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): NCT00527410
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|