Clinical Trial DRUG AAA-III-01
- A Multicentre, Stratified, Open, Randomized, Comparator-Controlled, Parallelgroup Phase III Study Comparing Treatment with 177lu-Dota0-Tyr3-Octreotate to Octreotide Lar in Patients with Inoperable, Progressive, Somatostatin Receptor Positive, Midgut Carcinoid Tumours.
- Principal Investigator
- Al Benson III
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG AAA-III-01
- The purpose of this study is to compare two treatments: Octreotide LAR, currently considered as the standard treatment, and Tumor-targeted Peptide Receptor Radionuclide Therapy (PRRT). PRRT treatment is based on the administration of a radioactive product, Lutathera.
- PRRT is a form of molecular targeted treatment that is performed by the use of a small radioactive molecule. This small molecule, once injected into the body, is attracted to some specific sites on tumors, like iron is attracted to magnets. These specific tumor sites (the “magnets”) are called Receptors. The small molecule is called a Peptide (the “iron”) and it is similar to a peptide that exists naturally in the human body. In particular, this peptide is very similar to somatostatin, which is present in the neuro-endocrine system of the human body. The Peptide is attached to a radioactive material, also called a Radionuclide. The radionuclide contains high energy and can destroy cells. Because this radionuclide is attached to the Peptide, the radiation can be targeted to the Receptors on the tumor site. This makes PRRT a form of targeted therapy. Lutathera is a somatostatin analogue that has been attached to a radioactive drug that delivers strong radiation directly into the tumor and works by causing death of the tissues affected by cancer. The radioactive drug works in the same way that normal radiotherapy works. The intent of giving the drug this way is that it should focus the effects and side effects on the tissues with cancer and have less effect on the healthy tissues. Octreotide LAR is a somatostatin analogue (a man-made drug that has a chemical structure that has been designed to mimic the hormone somatostatin). This drug is not radioactive. It reduces or stops the release of pituitary growth hormone and tries to stop the endocrine secretions from the pancreas (Release of various hormones from the pancreas), stomach and intestine. By doing this, it gives relief of symptoms in patients with midgut carcinoid syndromes.
Some of the eligibility criteria include:
- Participants in this study must have a carcinoid tumor that may not be removed by surgery.
- Participants must have disease that is getting worse (it is progressive).
- Participants must be 18 or older.
- Description of Treatment
- The study will consist of a treatment phase of about 1.5 years. During the treatment phase, participants will receive either 4 administrations of Lutathera every 8 weeks, followed by monthly administrations of Octreotate LAR or monthly administrations of Octreotate LAR for at least 19 months.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 01-Oct-16 03:41 AM
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