A Phase I Dose-Finding and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent or Refractory Anaplastic Astrocytoma (AA), Anaplastic Oligodendroglioma (AO), Anaplastic Mixed Oligo-Astrocytoma (AOA), Glioblastoma Multiforme (GBM) or Gliosarcoma (GS), With or Without Concurrent Treatment With Enzyme-Inducing Anticonvulsant Therapy
Malignant gliomas, glioblastoma multiforme and anaplastic astrocytoma, are rapidly growing
primary brain tumors associated with a high degree of morbidity and mortality. Despite
aggressive treatment, the median survival rate for GBM is approximately 12 months, with
two-year survival rates no more than 8 to 12%, while median survival for patients with AA
ranges from 2 to 3 years from time of first diagnosis.
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. It will be
administered by i.v. infusions either daily for 3 consecutive days repeated every three
weeks, or once weekly for 4 consecutive weeks repeated every 5 weeks. Once the maximum
tolerated dose is determined , a new group of patients will be enrolled into the study to
evaluate the tolerability and MTD when administered on an expanded schedule (once a week).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of RTA 744 Injection in the patient population studied and to determine the qualitative and quantitative toxic effects of RTA 744 Injection.
at end of first cycle for each patient cohort
United States: Food and Drug Administration
|The University of Texas M. D. Anderson Cancer Center||Houston, Texas 77030|
|University of Texas Southwestern Medical Center||Dallas, Texas|
|UCLA School of Medicine, Department of Neurology||Los Angeles, California 90095|
|Baylor University Medical Center: Neuro-Oncology Associates||Dallas, Texas 75246|