Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

Stanford University

Status and phase: Enrolling; Phase 1

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Treatments: Procedure: Magnetic Resonance Imaging (MRI); Drug: Gallium 68 Dotatate; Procedure: PET/CT; Procedure: Computed Tomography (CT); Drug: Lutathera

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04609592

NCI-2021-03448 (Registry Identifier)

IRB-52341

NET0030 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, liver and kidney function
9. Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study

Exclusion criteria

1. Prior 177Lu Dotatate treatment
2. Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to > 25% of bone marrow, at any time
3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study
4. Known brain metastases
5. Known bone or peritoneal metastases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Lutathera

Experimental group

Description:

2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT

Treatment:

Drug: Lutathera

Procedure: Computed Tomography (CT)

Procedure: PET/CT

Drug: Gallium 68 Dotatate

Procedure: Magnetic Resonance Imaging (MRI)