A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic Meningitis (LMD)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Safety and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent, Progressive or Refractory Neoplastic Meningitis|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Document any potential antitumor activity. [ Time Frame: after every even numbered treatment cycle ] [ Designated as safety issue: No ]
- Correlate pharmacokinetic information with clinical (efficacy and safety) responses. [ Time Frame: end of study ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527410
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|