FDA Approves Amendment for PRRT Clinical Trial in Texas

BREAKING NEWS:  The Food and Drug Administration (FDA) has just approved the RadioIsotope Therapy of America (RITA) Foundation’s amendment to the Investigational New Drug (IND) protocol for intra-hepatic artery administration of Lu-177 Octreotate in patients who have predominately liver metastasis from neuroendocrine cancers. August 15, 2012 marks the date for the treatment of the first patient with intra-hepatic artery administration at Excel Diagnostics & Nuclear Oncology Center in Houston, Texas.

RITA Foundation in Texas is one of the collaborators on the first PRRT clinical trial in the United States for neuroendocrine cancer patients

The clinical trial of Lutetium-177 (Lu-177) with Octreotate is the first in North America for neuroendocrine cancer patients.  The trial began in September 2010 and represents a milestone in treatment options for carcinoid and NET (neuroendocrine tumor) cancer patients.  The clinical trial is being conducted at Excel Diagnostics in Houston, Texas, and is a collaboration of BioSynthema, Inc. of  St. Louis, Missouri, and Baylor College of Medicine, St. Luke’s Episcopal Hospital, and the RITA Foundation, all in Houston, Texas.

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, India, and just recently began in Singapore. 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 17 years, studies of radio-peptide therapy for various neuroendocrine cancers have shown good clinical and radiological results with minimal side effects.

Ebrahim S. Delpassand, MD, principal investigator for the U.S. program, said of the new FDA approval, “We are extremely pleased regarding the recent approval of FDA for this Ebrahim S. Delpassand, MD, is the principal investigator for the first PRRT clinicial trial in the United States, a milestone treatment for neuroendocrine cancer.preferential administration of Lu-177 Octreotate in patients who have predominantly liver metastases. The majority of NET patients referred for PRRT have significant liver involvement and this method of administration will expose the cancer lesions to the highest concentration of the medication. I anticipate the effectiveness for treating liver lesions with this method of administration will be 4 to 5 times higher than systemic intravenous administration. This is definitely an exciting milestone in the fight against neuroendocrine cancers.”

For further information regarding this treatment, contact Ms. Susan Cork, clinical coordinator of the project, at 713-341-3203 or scork@exceldiagnostics.com.

To read our blog about the FDA’s 2010 approval of the clinical trial, CLICK HERE.

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One Response to FDA Approves Amendment for PRRT Clinical Trial in Texas

  1. Juana Tijerina says:

    My daughther has carcinoid cancer it has metastastes to the liver she has being diagnois for almost a year getting treatments at MD Anderson. With treatments however her tumors keep getting larger.She gets her monthly shots for systom control and takes an everolimus oral inhibitor. Still her tumors are aggressively growing. Do you think this new treatment is worth mentioning to her Dr at MD Anderson? Do you think this treatment might benefit her.Her Age is 41.

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