Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery
Stanford University
Summary
The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.
Description
Primary Objective(s) * To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s) * To assess response rate (RR) after 2 cycles 177Lu Dotatate * To assess recurrence free survival (RFS) of the overall treatment strategy * To assess overall survival (OS) of the overall treatment strategy
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only. 2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford) 3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion 4. Measurable disease as determined by RECIST v1.1 5. Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan 6. Patients ≥ 18 years of age. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1 8. Appropriate hematologic,…
Interventions
- DrugLutathera
4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T
- DrugGallium 68 Dotatate
Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)
- ProcedureComputed Tomography (CT)
Medical Imaging
- ProcedureMagnetic Resonance Imaging (MRI)
Medical Imaging
- ProcedurePET/CT
Medical Imaging
Location
- Stanford Cancer Institute Palo AltoStanford, California