FDA Approves Novel Radio-peptide Targeted Therapy Clinical Trial for Neuroendocrine Cancer: PRRT (Peptide Receptor Radionuclide Therapy)

For the first time in North America, neuroendocrine cancer patients will have the opportunity to participate in a clinical trial of Lutetieum-177 (LU-177)with Octreotate. Ebrahim S. Delpassand, MD, chief executive officer and medical director of Excel Diagnostics, has announced that after several years of careful review the Food and Drug Administration (FDA) has approved the investigational new drug clinical trial. Excel Diagnostics Imaging Clinics in Houston, Texas is the first research facility in the United States to receive authorization to initiate this much needed therapy.

Ebrahim Delpassand and neuroendocrine cancer clinical trial and PRRT

Dr. Ebrahim Delpassand

Lutetieum-177 radionuclide is one of the radioactive materials used in PRRT, peptide receptor radionuclide therapy, as is Y-90 (Yttrium-90). When labeled with somatostatin analogs such as Octreotate, these agents can be used for progressive neuroendocrine tumors that are resistant to octreotide/interferon treatment or chemotherapy. LU-177 Octreotate has been used in Europe for over a decade and is also available in Australia and India. It has a shorter path length in the tissue than Y-90 has and is less toxic to both the kidneys and bone marrow. During the past 15 years, studies of radio-peptide therapy for various neuroendocrine cancers have shown good clinical and radiological results with minimal side effects.

LU-177 Octreotate is administered along with intravenous amino acids, to protect the kidneys from radiation. The Octreotate binds to somatostatin receptors on cells, thus providing highly targeted radiation to the tumors. A patient has 4 sessions of the treatment, spaced six to ten weeks apart. The use of LU-177 Octreotate as a targeted treatment was pioneered by Dr. Eric Krenning and Dr. Dik J. Kwekkeboom at Erasmus Medical Center in Rotterdam, the Netherlands.

This therapy can be used for neuroendocrine tumors including carcinoid, islet cell carcinoma of the pancreas, oat cell carcinoma of the lung, pheochromocytoma, gastro-entero-pancreatic neuroendocrine tumors (GEPNETS), and rare thyroid cancers unresponsive to radioiodine.

The principal investigator for the U.S. program is Dr. Delpassand and the project is in collaboration with Baylor College of Medicine, St. Luke’s Episcopal Hospital and Radio-Isotope Therapy of America (RITA) Foundation in Houston. According to Dr. Delpassand, “We are very pleased this therapy has been approved by the FDA and we are anxious to start these treatments for patients.”  Financial arrangements, both cost and insurance coverage, are still to be determined.

For further information regarding this treatment, which will be available beginning in September, contact Ms. Christiane Assir, clinical coordinator of the project, at 713-341-3239 or cassir@exceldiagnostics.com. (Update:  as of 2011 the coordinator is Ms. Susan Cork, 713-341-3203 or scork@exceldiagnostics.com.)

Neuroendocrine Cancer Clinical Trial and Excel Diagnostics and PRRT

Dr. Delpassand, Excel’s founder and director, is the former deputy chairman, associate professor and chief of clinical nuclear medicine at M.D. Anderson Cancer Center in Houston, Texas.  His established track record and extensive experience include the disciplines of therapeutic nuclear medicine, nuclear cardiology, monoclonal antibody imaging, and positron emission tomography (PET). He maintains voluntary appointments at the University of Texas Medical Branch, Department of Radiation Oncology, and Baylor College of Medicine, Department of Radiology.

In 2008, the Carcinoid Cancer Foundation helped support the initiation of Dr. Delpassand’s research on LU-177 with a substantial grant. “We at the Carcinoid Cancer Foundation believe strongly in the importance of this therapy for neuroendocrine cancer patients and are very excited that it will finally be offered for the first time in the United States. The goal of LU-177 treatment for patients is to reduce tumor growth and increase longevity and the quality of life,” said Richard R.P.Warner, MD, a nationally and internationally recognized carcinoid and neuroendocrine cancer specialist, who is Director of the Center for Carcinoid and Neuroendocrine Tumors at the Mount Sinai Hospital in New York City and Medical Director of the Carcinoid Cancer Foundation.

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