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Trial record 49 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT03724409
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
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

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: [90]Y-DOTATOC Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Official Title: Selective Intra-arterial Injection of Peptide Receptor Radionuclide Therapy (PRRT) in Neuroendocrine Tumor Patients With Liver Metastases
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
Subject will be administered 2.96 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
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

Experimental: Cohort 2
Subject will be administered 3.33 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
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

Experimental: Cohort 3
Subject will be administered 3.7 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
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

Experimental: Cohort 4
Subject will be administered 4.17 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
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

Experimental: Cohort 5
Subject will be administered 4.44 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
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

Experimental: Cohort 6
Subject will be administered 5.18 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 90Y-DOTATOC distribution [ Time Frame: 48h post-infusion ]
    Determine the distribution of 90Y-DOTATOC using post-treatment imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724409


Contacts
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Contact: Sandeep Laroia, MD (319) 356-3859 sandeep-laroia@uiowa.edu
Contact: Yusuf Menda, MD (319) 356-3214 yusuf-menda@uiowa.edu

Locations
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United States, Iowa
The Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Kristin Gaimari-Varner, RN, BSN    319-384-5489    kristin-gaimari-varner@uiowa.edu   
Contact: Veronica Howsare    (319) 384-6469    veronica-howsare@uiowa.edu   
Sponsors and Collaborators
Sandeep Laroia
National Institutes of Health (NIH)
Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: M. S O'Dorisio, MD, PhD University of Iowa
Principal Investigator: Sandeep Laroia, MD University of Iowa

Publications:
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Responsible Party: Sandeep Laroia, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03724409     History of Changes
Other Study ID Numbers: 201805910
P50CA174521 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandeep Laroia, University of Iowa:
PRRT
Radionuclide
DOTATOC
intra-arterial
peptide receptor radiotherapy

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Edotreotide
Octreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents