Clinical Trials Using Lutetium Lu 177 Dotatate

Clinical trials are research studies that involve people. The clinical trials on this list are studying Lutetium Lu 177 Dotatate. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-11 of 11
  • Nivolumab and Lutetium Lu 177-DOTA-TATE in Treating Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer or Grade I-II Lung Neuroendocrine Tumors That Are Advanced or Cannot Be Removed by Surgery

    This partially randomized phase I / II trial studies the best dose of lutetium Lu 177-tetra-azacyclododecanetetra-acetic acid (DOTA)-Tyr3-octreotate (TATE) when given together with nivolumab and to see how well they work in treating patients with extensive-stage small cell lung cancer that has come back or does not respond to treatment or grade I-II lung neuroendocrine tumors that have spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as nivolmuab, may interfere with the ability of tumor cells to grow and spread. Radioactive drugs, such as lutetium Lu 177-DOTA-TATE, may carry radiation directly to tumor cells and not harm normal cells. Giving nivolumab and lutetium Lu 177-DOTA-TATE may work better in treating patients with small cell lung cancer or long neuroendocrine tumors.
    Location: 7 locations

  • Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors

    This phase I trial studies the side effects and best dose of triapine when given together with lutetium Lu 177 dotatate in treating patients with neuroendocrine tumors. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. Giving triapine and lutetium Lu 177 dotatate together may be a good way in treating patients with neuroendocrine tumors.
    Location: University of Kentucky / Markey Cancer Center, Lexington, Kentucky

  • Lutathera for the Treatment of Inoperable, Progressive Meningioma after External Beam Radiation Therapy

    This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill cancer cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

    The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
    Location: M D Anderson Cancer Center, Houston, Texas

  • 177Lu-DOTATATE in Treating Patients with Progressive or High-Risk Grade I-III Meningioma

    This phase II trial studies how well 177Lu-DOTATATE works in treating patients with grade I-III meningioma that is growing, spreading, or getting worse or that is high-risk. 177Lu-DOTATATE is a radioactive drug the binds to the hormone receptor somatostatin, type 2, which is found on the surface of meningioma tumor cells. The radioactivity of 177Lu-DOTATATE may kill the tumor cells.
    Location: 3 locations

  • Pembrolizumab and Liver-Directed Therapy or Peptide Receptor Radionuclide Therapy in Treating Patients with Well-Differentiated Neuroendocrine Tumors and Symptomatic and / or Progressive Liver Metastases

    This phase II trial studies how effective pembrolizumab and liver-directed therapy or peptide receptor radionuclide therapy are at treating patients with well-differentiated neuroendocrine tumors and symptomatic and / or progressive tumors that have spread to the liver (liver metastases). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Liver-directed therapies such as radiofrequency ablation, transarterial embolization, yttrium-90 microsphere radioembolization, and cryoablation may help activate the immune system in order to shrink tumors that are not being directly targeted. Peptide receptor radionuclide therapy is a form of targeted treatment that is performed by the use of a small molecule, which carries a radioactive component attached to a peptide. Once injected into the body, this small molecule binds to some specific sites on tumor cells called receptors and emit medium energy radiation that can destroy cells. Because this radionuclide is attached to the peptide, which binds receptors on tumor lesions, the radiation can preferably be targeted to the tumor cells in order to destroy them. Giving pembrolizumab in combination with liver-directed therapy or peptide receptor radionuclide therapy may work better than pembrolizumab alone.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma / Paraganglioma

    Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET / CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.
    Location: 2 locations

  • Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

    Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. Eligibility: Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells. Design: Participants will be screened under protocol 01-C-0129. They may have a tumor biopsy. Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein. Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses. During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer. Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Peptide Receptor Radiotherapy with 177Lu-DOTATATE for the Treatment of Recurrent, Refractory, or Unresectable Neuroendocrine Tumors, Neuroblastoma, Pheochromocytoma, or Paraganglioma

    This phase I / II trial studies the side effects of peptide receptor radiotherapy with 177Lu-DOTATATE and to see how well it works in treating patients with neuroendocrine tumors, neuroblastoma, pheochromocytoma, or paraganglioma that has come back (recurrent), has not responded to treatment (refractory), or cannot be removed by surgery (unresectable). Peptide receptor radiotherapy is a type of radiation therapy where a radioactive chemical, 177Lu-DOTATATE, is linked to a peptide (small protein) that targets cancer cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some cancer cells. The radioactive peptide builds up in these cells and helps kill the cancer cells without harming normal cells.
    Location: University of Iowa / Holden Comprehensive Cancer Center, Iowa City, Iowa

  • Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers

    This phase II trial studies how well 177Lu-DOTATATE works in treating patients with rare endocrine cancers that have spread from where they started to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Radioactive drugs, such as 177Lu-DOTATATE, may carry radiation directly to cancer cells and not harm normal cells. 177Lu-DOTATATE may help to control endocrine cancers compared to standard treatment.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Post-Authorization Long-Term Safety Study of LUTATHERA

    Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC / USPI).
    Location: UCSF Medical Center-Mount Zion, San Francisco, California