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Neuroendocrine TumorsEarly Phase 1NCT03724409

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

A Early Phase 1 study testing [90]Y-DOTATOC in people with Neuroendocrine Tumors, run by Sandeep Laroia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
[90]Y-DOTATOC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
11 Oct 2018to 23 May 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
[90]Y-DOTATOC
Keywords
PRRT, Radionuclide, DOTATOC, intra-arterial, peptide receptor radiotherapy
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [90]Y-DOTATOCDrug

    Also called 90Y-DOTATOC, 90Y-DOTA-Phe1-tyr3-Octreotide, [90]Yttrium-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.

Study groups in NCT03724409
Study groupRoleWhat they receive
Cohort 1ExperimentalSubject will be administered 2.96 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Receives: Drug: [90]Y-DOTATOC
Cohort 2ExperimentalSubject will be administered 3.33 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Receives: Drug: [90]Y-DOTATOC
Cohort 3ExperimentalSubject will be administered 3.7 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Receives: Drug: [90]Y-DOTATOC
Cohort 4ExperimentalSubject will be administered 4.17 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Receives: Drug: [90]Y-DOTATOC
Cohort 5ExperimentalSubject will be administered 4.44 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Receives: Drug: [90]Y-DOTATOC
Cohort 6ExperimentalSubject will be administered 5.18 gigabecquerels of [90]Y-DOTATOC intra-aterially to the liver
Receives: Drug: [90]Y-DOTATOC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in liver enzymes

    Evaluate liver toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for liver enzymes

    Measured: Through 6 weeks after treatment

  2. Change in platelet counts

    Evaluate bone marrow toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) severity scale for platelet count

    Measured: Through 6 weeks after treatment

  3. 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

    Measured: Through 6 weeks after treatment

Secondary outcomes (1)

  1. 90Y-DOTATOC distribution

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

    Measured: 48h post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start11 Oct 2018
  3. Primary completion21 Mar 2021
  4. Study completion23 May 2023

Why it stopped: Pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a sequential early phase 1 study using Storer's phase 1 design B.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03724409
Sponsor's protocol ID
201805910
Other IDs
P50CA174521
Status last verified
Nov 2023
First submitted
25 Oct 2018
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 25186181

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [90]Y-DOTATOC in people with Neuroendocrine Tumors, run by Sandeep Laroia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Pandemic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in liver enzymes (time frame: Through 6 weeks after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03724409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.

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