Applying to new Clinical Trial in NYC

A Study to Assess the Use of Radiolabeled DOTA-JR11 to Diagnose and Treat Neuroendocrine Tumors

         

Full Title

Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients with Neuroendocrine Tumors

Purpose

The purpose of this study is to assess the use of a peptide called DOTA-JR11 to locate and treat metastatic or inoperable neuroendocrine tumors. DOTA-JR11 is similar to a natural hormone called somatostatin. Receptors for somatostatin are commonly found on the surface of neuroendocrine tumors.
In the first part of this study, DOTA-JR11 will be attached to a radioactive substance called gallium-68 and will be given to patients intravenously (by vein). Through PET scanning, researchers can see where the DOTA-JR11 binds, indicating a tumor contains somatostatin receptors. The gallium-68 makes the location of these receptors visible on the PET scan.
In the second part of the study, researchers will attach radioactive lutetium-177 to DOTA-JR11. DOTA-JR11 will bind to a patient's tumor cells in the same way as gallium-68 DOTA-JR11, and it is hoped that the radiation from lutetium-177 will kill those cells. In this part of the study, researchers will determine the safe dose of lutetium-labeled DOTA-JR11 and also examine the drug's effectiveness for treating neuroendocrine tumors.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have a carcinoid or pancreatic neuroendocrine tumor that is metastatic or inoperable.
• At least 4 weeks must pass between the completion of chemotherapy and 6 weeks since local therapies and entry into the study.
• Patients may not have previously received prior radiolabeled therapy (including SIRTs).
• Patients' blood counts must be within normal limits.
• Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
• This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wolfgang Weber at 212-639-7373 or Dr. Diane Reidy-Lagunes at 646-888-4185.

Protocol

15-161

Phase

Pilot

Disease Status

Relapsed or Refractory

Investigator

Wolfgang A. Weber

Co-Investigators

Neeta Pandit-Taskar

Diane Reidy Lagunes

Diseases

Upper Gastrointestinal › Neuroendocrine

Locations

Memorial Hospital