Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver

NCT04544098 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 20-232
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at whether it is practical and safe to give Lutathera directly into an artery of the liver (hepatic intraarterial infusion). The researchers will compare the effects of hepatic intraarterial infusion in the liver with the effects of the standard approach (intravenous infusion in the arm). The researchers will also determine whether Lutathera is effective against participants' cancer.

Conditions

Neuroendocrine Tumors; Liver-Dominant Metastatic Pancreatic Neuroendocrine Tumors

Keywords

177Lu-DOTATATE; Pan-NETs; Intrahepatic Arterial; Intravenous Infusion; Gastroenteropancreatic (GEP),; Bronchial or Unknown Primary Well Differentiated Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• number of patients who successfully complete 2 IA injections

  Feasibility will be defined as at least 7 or more patients out of 10 patients who successfully complete 2 IA injections.

  2 years

• Objective response

  classified according to RECIST 1.1 criteria

  1 year

Study Arms (1)

PRRT with 177Lu-DOTATATE

EXPERIMENTAL

Patients will undergo a routine 68Ga-DOTATATE PET/CT. Patients with sufficient tumor uptake will be offered therapy with 177Lu-DOTATATE. The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration.

Drug: 177Lu-DOTATATE

Interventions

177Lu-DOTATATE DRUG

The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration. The activity per cycle will be fixed for each patient: patients will receive two intra-arterial cycles of 7.4 GBq, unless toxicity occurs requiring dose modifications.

PRRT with 177Lu-DOTATATE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects affected by histologically proven, somatostatin-receptor positive, progressive, nonresectable, liver-dominant metastatic GEP, bronchial or unknown primary tumors, G1, G2 and G3, according to the new WHO classification of 2017.
• Ability to understand and willingness to sign a written informed consent document
• Aged 18 years or older
• Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization
• Measurable disease as defined by RECIST 1.1 with at least one dimension ≥ 1.0 cm
• GEP or unknown primary NET of grade 1, 2 and 3 according to WHO 2017, typical or atypical lung carcinoid according to the Travis classification of 2004
• Progression of disease defined by one of the following occurring within 6 months of study entry:
• At least a 20% increase in radiologically or clinically measurable disease;
• Appearance of any new lesion;
• Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden);
• Overexpression of somatostatin receptors of the target lesions at 68Ga-DOTATATE PET/CT with SUV of lesions greater than normal liver at least in 1 metastasis.
• ECOG performance status 0 or 1 (Karnofsky ≥ 70%).
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed \>6 weeks prior to study entry. For such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry.
• Previous oral chemotherapy, biotherapy (such as Interferons or Everolimus) and/or investigational agents are allowed if completed \>4 weeks prior to study entry For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.

You may not qualify if:

• Women who are pregnant or breastfeeding
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTATATE as assessed from medical records.
• Life expectancy \< 6 months as assessed by the treating physician.
• Over 80% liver involvement by tumor per the judgement of the radiologist
• Poorly differentiated neuroendocrine neoplasms (Neuroendocrine Carcinoma), small and large cell type; Mixed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
• Presence of somatostatin receptor negative lesions.
• Prior treatment with other radiolabeled somatostatin analogs.
• Prior systemic chemotherapy, except oral chemotherapy with capecitabine + temozolomide
• Contraindication to angiography/embolization including:
• Patients cannot receive contrast
• Severe allergic reaction to contrast despite premedication. Patients in who IV contrast is contraindicated are recommended to have MRI abdomen and noncontrast chest CT scan.
• Poor renal function not on dialysis
• Other, based on judgment of the investigator
• Main portal vein tumor thrombus.
• Deteriorated renal function:

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Lisa Bodei, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an early-phase trial in which a total of 10 patients with progressive, inoperable, liver-dominant, metastatic GEP, bronchial or unknown primary NETs will be enrolled in this combined intraarterial/intravenous therapeutic approach with 177Lu-DOTATATE.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: September 2, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)