Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03724409
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sandeep Laroia, University of Iowa

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE October 11, 2018
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • Change in liver enzymes [ Time Frame: Through 6 weeks after treatment ]
    Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes
  • Change in platelet counts [ Time Frame: Through 6 weeks after treatment ]
    Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count
  • Change in absolute neutrophil count [ Time Frame: Through 6 weeks after treatment ]
    Evaluate bone marrow toxicity using using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for absolute neutrophil count
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
90Y-DOTATOC distribution [ Time Frame: 48h post-infusion ]
Determine the distribution of 90Y-DOTATOC using post-treatment imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Intra-arterial Injection of PRRT in Neuroendocrine Tumor Patients With Liver Metastases
Official Title  ICMJE Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
This is a sequential early phase 1 study using Storer's phase 1 design B.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: [90]Y-DOTATOC
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.
Other Names:
  • 90Y-DOTATOC
  • 90Y-DOTA-Phe1-tyr3-Octreotide
  • [90]Yttrium-DOTATOC
Study Arms  ICMJE
  • Experimental: Cohort 1
    Subject will be administered 2.96 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
    Intervention: Drug: [90]Y-DOTATOC
  • Experimental: Cohort 2
    Subject will be administered 3.33 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
    Intervention: Drug: [90]Y-DOTATOC
  • Experimental: Cohort 3
    Subject will be administered 3.7 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
    Intervention: Drug: [90]Y-DOTATOC
  • Experimental: Cohort 4
    Subject will be administered 4.17 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
    Intervention: Drug: [90]Y-DOTATOC
  • Experimental: Cohort 5
    Subject will be administered 4.44 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
    Intervention: Drug: [90]Y-DOTATOC
  • Experimental: Cohort 6
    Subject will be administered 5.18 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
    Intervention: Drug: [90]Y-DOTATOC
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandeep Laroia, MD (319) 356-3859 sandeep-laroia@uiowa.edu
Contact: Yusuf Menda, MD (319) 356-3214 yusuf-menda@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03724409
Other Study ID Numbers  ICMJE 201805910
P50CA174521 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Considered upon request.
Access Criteria: Contact study PI regarding data sharing. A non-disclosure agreement may be required between institutions dependent upon the data requested.
Responsible Party Sandeep Laroia, University of Iowa
Study Sponsor  ICMJE Sandeep Laroia
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Holden Comprehensive Cancer Center
  • National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: M. S O'Dorisio, MD, PhD University of Iowa
Principal Investigator: Sandeep Laroia, MD University of Iowa
PRS Account University of Iowa
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP