A new phase 2 clinical trial conducted at NYU Langone’s Perlmutter Cancer Center offers treatment for patients with unresectable and progressive meningiomas that have failed prior therapies. While most meningiomas are considered benign or respond well to existing treatments, about 10 to 15 percent of these tumors demonstrate aggressive clinical behavior, continuing to grow after multiple resections and radiotherapy sessions.

“For patients with progressive meningiomas, there are no established medical treatment options demonstrated to be effective,” says Sylvia C. Kurz, MD, PhD, assistant professor in the Department of Neurology and a co-investigator of the trial along with Elcin Zan, MD, assistant professor in the Department of Radiology.

The largest of its kind in the United States, the trial tests the efficacy of a radionuclide-linked peptide called 177Lutetium-DOTATATE, or Lutathera®, that targets somatostatin receptor type 2, which is uniformly expressed in meningiomas. The U.S. Food and Drug Administration has recently approved Lutathera® for well-differentiated neuroendocrine tumors. The same dosing regimen—200 mCi administered every 8 weeks, for a total of 4 doses—is being used for progressive meningiomas.

Potential patients are being identified and evaluated by Dr. Kurz and the trial’s principal investigator, Erik P. Sulman, MD, PhD, co-director of the Brain and Spine Tumor Center and vice chair for research and professor in the Department of Radiation Oncology. As part of the study, a novel imaging probe called 68Ga-DOTATATE PET MRI is being used as a potential biomarker to identify patients who benefit from treatment with Lutathera® and to monitor treatment response over time.

“This trial holds great promise for patients with progressive meningiomas,” says Dr. Zan. “This is the first trial using a novel and nonsurgical targeted drug design method for a disease that has limited therapeutic options.”