Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04544098
Other study ID # 20-232
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date September 2, 2020
Est. completion date September 2025

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. 1. Ability to understand and willingness to sign a written informed consent document 2. Aged 18 years or older 3. Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization 4. Measurable disease as defined by RECIST 1.1 with at least one dimension = 1.0 cm 5. 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 6. Progression of disease defined by one of the following occurring within 6 months of study entry: 1. At least a 20% increase in radiologically or clinically measurable disease; 2. Appearance of any new lesion; 3. Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden); 7. 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. 8. ECOG performance status 0 or 1 (Karnofsky = 70%). 9. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. 10. 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. 11. 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. 12. Patients must not be candidate for potentially curative surgery. Prior surgery is allowed no less than 6 weeks prior to study entry. Note: Patients who have disease that is amendable to resection but who are not a surgical candidate for other medical reasons would be permitted. Exclusion Criteria: 1. Women who are pregnant or breastfeeding 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTATATE as assessed from medical records. 3. Life expectancy < 6 months as assessed by the treating physician. 4. Over 80% liver involvement by tumor per the judgement of the radiologist 5. Poorly differentiated neuroendocrine neoplasms (Neuroendocrine Carcinoma), small and large cell type; Mixed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN). 6. Presence of somatostatin receptor negative lesions. 7. Prior treatment with other radiolabeled somatostatin analogs. 8. Prior systemic chemotherapy, except oral chemotherapy with capecitabine + temozolomide 9. Contraindication to angiography/embolization including: 1. Patients cannot receive contrast 2. 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. 3. Poor renal function not on dialysis 4. Other, based on judgment of the investigator 10. Main portal vein tumor thrombus. 11. Deteriorated renal function: 1. Serum creatinine >1.7 mg/dL OR 2. EGFR <30 ml/min 12. Deteriorated bone marrow function: 1. Hb <8.0 g/dL; 2. WBC <3000/mm3; 3. ANC<1500/mm3; 4. Platelets <75.000/mm3 13. Deteriorated liver function: 1. INR > 2.0 for patients that are not on Coumadin or Xarelto 2. PTT > 2x ULN 3. Total bilirubin >3 mg/dl 4. Serum albumin <3.0 g/dL unless prothrombin time is within the normal range. 14. Clinically relevant toxicities from prior therapies that have not resolved to grade 1 or grade 0 15. Previous liver radioembolization with 90Y-microspheres. 16. Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized. 17. Uncontrolled diabetes mellitus 18. Inability to interrupt short-acting Octreotide for 24 h before and 24 h after the administration of 177Lu-DOTATATE; inability to have an interval between Octreotide LAR and 177Lu-DOTATATE of =4 weeks 19. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 20. Prior external beam radiation therapy involving >25% of the bone marrow. 21. Unmanageable urinary incontinence rendering the administration of 177Lu-DOTATATE unsafe 22. Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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. 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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Objective response classified according to RECIST 1.1 criteria 1 year
See also
  Status Clinical Trial Phase
Completed NCT01218555 - Study of Everolimus (RAD001) in Combination With Lenalidomide Phase 1
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Withdrawn NCT04614766 - A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors Phase 1/Phase 2
Recruiting NCT05556473 - F-Tryptophan PET/CT in Human Cancers Phase 1
Completed NCT03273712 - Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) Phase 2
Recruiting NCT05636618 - Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors Phase 1/Phase 2
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Completed NCT02815969 - The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors
Completed NCT02441062 - Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors Phase 2
Active, not recruiting NCT02174549 - Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer Phase 1/Phase 2
Completed NCT02132468 - A Ph 2 Study of Fosbretabulin in Subjects w Pancreatic or Gastrointestinal Neuroendocrine Tumors w Elevated Biomarkers Phase 2
Completed NCT02134639 - PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation N/A
Recruiting NCT01201096 - Neo-adjuvant Peptide Receptor Mediated Radiotherapy With 177Lutetium in Front of Curative Intended Liver Transplantation in Patients With Hepatic Metastasis of Neuroendocrine Tumors (NEO-LEBE) N/A
Terminated NCT01163526 - Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies N/A
Completed NCT01099228 - Combination Targeted Radiotherapy in Neuroendocrine Tumors N/A
Completed NCT00171873 - Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut Phase 3
Active, not recruiting NCT05077384 - Open-label Study of Surufatinib in Japanese Patients Phase 1/Phase 2
Active, not recruiting NCT02736500 - Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors Phase 1/Phase 2
Completed NCT00978211 - DOTA-TOC in Metastasized Neuroendocrine Tumors Phase 2