The U.S. National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies. For additional clinical trials contact the NCI's Cancer Information service at 800-422-6237
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 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 (pictured below), announced that after several years of careful review the Food and Drug Administration (FDA) has approved the investigational new drug clinical trial. Excel Diagnostics and Nuclear Oncology Center in Houston, Texas is the first research facility in the United States to receive authorization to initiate this much needed therapy.
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. Ebrahim S. 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.
For further information regarding this treatment, contact Ms. Susan Cork, therapy patient coordinator, at 713-341-3203 or firstname.lastname@example.org.
Tekmira Pharmaceuticals and Scottsdale Healthcare are conducting a clinical research study in patients with neuroendocrine tumors (NET) and adrenocortical carcinoma (ACC) at the following US Centers: Scottsdale Healthcare; Mayo Clinic, Scottsdale and Rochester locations; University of Iowa; and Moffitt Cancer Center.
This clinical research study is testing the study drug, TKM-080301, which is an investigational drug. TKM-080301 contains a small piece of synthetic RNA, called siRNA, which is designed to reduce a protein called PLK1. PLK1 is present at high levels in dividing cancer cells. By reducing PLK1, the study drug may be able to block the cancer cells from multiplying. In experiments performed in the laboratory with cancer cells and in mice, TKM-080301 has been shown to reduce PLK1.
During the early part of this study, all patients with solid tumors were eligible to participate. Based on early clinical results so far, Tekmira believes patients with NET and ACC may be particularly appropriate for treatment with this study drug and the study is now only enrolling these subjects. Participants entering the study now will receive the highest tolerated dose of TKM-080301 determined during the early part of the study.