A Phase I Safety and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent, Progressive or Refractory Neoplastic Meningitis
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor.
evaluation at end of cycle 1 for each cohort
United States: Food and Drug Administration
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|