A Phase I/II Trial of IL-13-PE in Patients With Treatment Refractory Malignancies With a Focus on Metastatic and Locally Advanced Adrenocortical Carcinoma
The investigators hypothesize that IL-13-PE will cause cancer regression in patients with
metastatic and locally advanced adrenocortical carcinoma (ACC) and other malignancies with
high IL13Rα2 expression level given the following:
- High levels of interleukin-13 receptor alpha 2 (IL13Rα2) are observed in ACC and in
malignant pheochromocytoma, pancreatic ductal adenocarcinoma, and hepatocellular
- IL13Rα2 regulates cellular proliferation and invasion of ACC cells.
- IL-13-PE is highly effective in causing cell death in IL13Rα2 positive ACC cells, and
causes tumor regression and prolonged survival in an ACC xenograft nude mice model.
The purposes of this study are:
- To determine the safety and maximal tolerated dose of IL-13-PE in patients with
metastatic and locally advanced ACC and other malignancies with high IL13Rα2 expression
- To determine response rate and progression-free survival in patients with recurrent,
metastatic, or primary unresectable ACC treated with IL-13-PE.
- Evaluate response to IL-13-PE with functional imaging as compared to axial imaging.
- Determine if response to IL-13-PE treatment is associated with IL13Rα2 expression
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose in Phase 1 of the study
Phase 1 of the study (up to 5 days)
Electron Kebebew, M.D.
National Institutes of Health (NIH)
United States: Food and Drug Administration
|NCI/NIH||Bethesda, Maryland 20892|