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

Primary Purpose

Neuroendocrine Tumors

Status
Suspended
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[90]Y-DOTATOC
Sponsored by
Sandeep Laroia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring PRRT, Radionuclide, DOTATOC, intra-arterial, peptide receptor radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Holden Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Arm Description

Subject will be administered 2.96 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver

Subject will be administered 3.33 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver

Subject will be administered 3.7 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver

Subject will be administered 4.17 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver

Subject will be administered 4.44 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver

Subject will be administered 5.18 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver

Outcomes

Primary Outcome Measures

Change in liver enzymes
Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes
Change in platelet counts
Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count
Change in absolute neutrophil count
Evaluate bone marrow toxicity using using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for absolute neutrophil count

Secondary Outcome Measures

90Y-DOTATOC distribution
Determine the distribution of 90Y-DOTATOC using post-treatment imaging

Full Information

First Posted
October 25, 2018
Last Updated
March 8, 2022
Sponsor
Sandeep Laroia
Collaborators
National Institutes of Health (NIH), Holden Comprehensive Cancer Center, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03724409
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Suspended
Why Stopped
Pandemic
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sandeep Laroia
Collaborators
National Institutes of Health (NIH), Holden Comprehensive Cancer Center, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
PRRT, Radionuclide, DOTATOC, intra-arterial, peptide receptor radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Model Description
This is a sequential early phase 1 study using Storer's phase 1 design B.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subject will be administered 2.96 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subject will be administered 3.33 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subject will be administered 3.7 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Subject will be administered 4.17 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Subject will be administered 4.44 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
Subject will be administered 5.18 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Intervention Type
Drug
Intervention Name(s)
[90]Y-DOTATOC
Other Intervention Name(s)
90Y-DOTATOC, 90Y-DOTA-Phe1-tyr3-Octreotide, [90]Yttrium-DOTATOC
Intervention Description
Intra-arterial infusion to the liver of [90]Y-DOTATOC. The administered dose is determined by cohort and is dependent upon the results of the previous cohort.
Primary Outcome Measure Information:
Title
Change in liver enzymes
Description
Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes
Time Frame
Through 6 weeks after treatment
Title
Change in platelet counts
Description
Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count
Time Frame
Through 6 weeks after treatment
Title
Change in absolute neutrophil count
Description
Evaluate bone marrow toxicity using using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for absolute neutrophil count
Time Frame
Through 6 weeks after treatment
Secondary Outcome Measure Information:
Title
90Y-DOTATOC distribution
Description
Determine the distribution of 90Y-DOTATOC using post-treatment imaging
Time Frame
48h post-infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. S O'Dorisio, MD, PhD
Organizational Affiliation
University of Iowa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandeep Laroia, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared as per approved IRB application and the subject's opt-in preferences. Data will not be provided from subjects who decline data sharing.
IPD Sharing Time Frame
Considered upon request.
IPD Sharing Access Criteria
Contact study PI regarding data sharing. A non-disclosure agreement may be required between institutions dependent upon the data requested.
Citations:
PubMed Identifier
25186181
Citation
Kennedy A, Bester L, Salem R, Sharma RA, Parks RW, Ruszniewski P; NET-Liver-Metastases Consensus Conference. Role of hepatic intra-arterial therapies in metastatic neuroendocrine tumours (NET): guidelines from the NET-Liver-Metastases Consensus Conference. HPB (Oxford). 2015 Jan;17(1):29-37. doi: 10.1111/hpb.12326. Epub 2014 Sep 4.
Results Reference
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Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases

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