Clinical Trials /

Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases

NCT03724409

Description:

This is a safety study to determine the phase 1 starting dose of [90]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

Related Conditions:
  • Metastatic Malignant Neoplasm in the Liver
  • Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases
  • Official Title: Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases

Clinical Trial IDs

  • ORG STUDY ID: 201805910
  • SECONDARY ID: P50CA174521
  • NCT ID: NCT03724409

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
[90]Y-DOTATOC90Y-DOTATOC, 90Y-DOTA-Phe1-tyr3-Octreotide, [90]Yttrium-DOTATOCCohort 1

Purpose

This is a safety study to determine the phase 1 starting dose of [90]Yttrium-DOTATOC when it is administered intravenously for patients with neuroendocrine tumors that have spread to the liver.

Detailed Description

      [90]Yttrium-DOTATOC is a radioactive drug used for peptide receptor radionuclide therapy
      (PRRT). In other studies, 90Y-DOTATOC has been administered through a vein (IV) to target
      somatostatin receptor positive tumor tissue. The DOTATOC identifies the tumor through the
      somatostatin receptor and links to it, attaching the radioactive molecule 90Yttrium to the
      malignant cell.

      This study expands the initial work to examine if administering the drug 90Y-DOTATOC directly
      to the liver is safe for patients with neuroendocrine tumors whose disease has spread to
      their tumor. We don't know how of the 90Y-DOTATOC is safe to administer. We want to learn
      what the maximum safe dose is and what the side effects are related to that dose.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalSubject will be administered 2.96 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
  • [90]Y-DOTATOC
Cohort 2ExperimentalSubject will be administered 3.33 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
  • [90]Y-DOTATOC
Cohort 3ExperimentalSubject will be administered 3.7 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
  • [90]Y-DOTATOC
Cohort 4ExperimentalSubject will be administered 4.17 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
  • [90]Y-DOTATOC
Cohort 5ExperimentalSubject will be administered 4.44 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
  • [90]Y-DOTATOC
Cohort 6ExperimentalSubject will be administered 5.18 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
  • [90]Y-DOTATOC

Eligibility Criteria

        Inclusion Criteria:

          -  Ability to understand and the willingness to provide informed consent

          -  Pathologically well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2).

          -  Primary tumor location should be known or believed to be midgut.

          -  At least one tumor in the liver that is positive with [68]Ga-DOTATATE (NETSPOT).
             Imaging must be performed within the past 6 months.

          -  Liver lesions not amendable to other therapies (surgery, ablation) and have progressed
             after treatment with octreotide/lanreotide and/or other treatments. (everolimus,
             sunitinib).

          -  Karnofsky performance status of at least 70

          -  Absolute neutrophil count of at least 1,000 cells/mm3

          -  Platelet count of at least 90,000 cells / mm3

          -  Total bilirubin ≤ 2 x the upper limit of normal when adjusted for age

          -  AST and ALT ≤ 5 x the upper limit of normal when adjusted for age

          -  Serum creatinine ≤ 1.2 mg/dl; if serum creatinine is >1.2 mg/dl nuclear GFR will used
             for potentially eligible participants.

          -  Agrees to contraception.

        Exclusion criteria:

          -  Liver tumor involvement greater than 70% by cross sectional imaging

          -  Extra-hepatic visceral and osseous metastases

          -  Concomitant therapy for tumor (except for somatostatin analogs or bisphosphonates)

          -  Previous PRRT or other liver directed therapy within 12 months of consent

          -  Women who are pregnant, breast feeding or breast pumping.

          -  Another concurrent malignancy on active therapy

          -  Previous external-beam radiation therapy to a kidney (including scatter dose)

          -  Therapeutic investigational drug within 4 weeks of therapy.

          -  Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of
             somatostatin analogue therapy represents a health risk.

          -  Sandostatin LAR injection within 4 weeks or lanreotide injection within 8 weeks of
             proposed therapy.

          -  Inability to lie down supine for study procedure.

          -  Reaction to IV contrast used for the angiogram.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection requiring hospitalization, symptomatic congestive heart failure, unstable
             angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
             would limit compliance with study requirements
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in liver enzymes
Time Frame:Through 6 weeks after treatment
Safety Issue:
Description:Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes

Secondary Outcome Measures

Measure:90Y-DOTATOC distribution
Time Frame:48h post-infusion
Safety Issue:
Description:Determine the distribution of 90Y-DOTATOC using post-treatment imaging

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sandeep Laroia

Trial Keywords

  • PRRT
  • Radionuclide
  • DOTATOC
  • intra-arterial
  • peptide receptor radiotherapy

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