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 email@example.com.
Lithium for Low-Grade Neuroendocrine Tumors. This study has been completed.
Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00501540
United States, Wisconsin University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, 53792, United States; Recruiting Cancer Connect 800-622-8922 Kelly Richie 608-263-7283 Kyle D Holen, MD, Principal Investigator
Study chairs or principal investigators
Kyle D Holen, MD, Principal Investigator, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Herbert Chen, MD, Study Chair, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center For more information CLICK HERE
http://www.clinicaltrials.gov/ct/show/NCT00388063?order=2 This study will evaluate the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma (Carcinoid/NET) who have metastatic or unresectable local-regional cancer and who have either symptoms ( diarrhea, flushing adn/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s). Contact Information: Craig C Talluto, PhD, abd 212-297-0010 Ext. 231 Cathy Clare, R.N. 212-207-0010 Ext. 234 Website
University of California, San Francisco Clinical Trial, ongoing but not recruiting
University of California, San Francisco (UCSF) Comprehensive Cancer Center - Clinical Trial Chemotherapy drugs like 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) work in different ways to cause tumor cells to stop growing or die. Bevacizumab is a monoclonal antibody that may inhibit cancer growth by blocking blood flow to tumors. Adding bevacizumab to combination chemotherapy may be a better way to block tumor growth than giving either type of therapy alone. The FOLFOX plus bevacizumab combination is being studied in patients with neuroendocrine tumors because FOLFOX appears to inhibit the growth of a variety of different tumor types but has not yet been tested in this disease. In addition, neuroendocrine tumors appear to depend on blood vessels for growth suggesting that they may respond to a treatment like bevacizumab. This clinical trial,which is ongoing but not recruiting, is for patients who have not responded to other treatments to see if the FOLFOX/bevacizumab combination is safe and if it can inhibit the growth of metastatic neuroendocrine tumors.
LOCATION AND CONTACT INFORMATION
Clinical Trials Recruitment Nurse UCSF Comprehensive Cancer Center Clinical Research Support Services 1600 Divisadero Street San Francisco, CA 94115 Tel: (415) 353-9612 Fax: (415) 353-9738