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Neuroendocrine TumorsPhase 2ILUMINETNCT01456078

A Multicenter Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors

A Phase 2 study testing 177Lu-DOTA-TATE in people with Neuroendocrine Tumors and Liver Metastases, run by Lund University Hospital at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

By improved kidney dosimetry including biological effective dose and taking into account potential risk factors (especially for kidney toxicity), it might be possible to give an optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic neuroendocrine tumor. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Neuroendocrine Tumors, Liver Metastases
What is being tested?
177Lu-DOTA-TATE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSweden
Study dates
Oct 2011to Nov 2018
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Step 1:
  • ECOG 0-2
  • Histologically verified neuroendocrine tumors with a Ki67 of at least 20 % or at least 20 mitoses/high power fields. If the tissue on which this determination is based is several years old, the investigator should consider the option of acquiring a new determination, especially if the behaviour of the tumor has changed since diagnosis
  • Metastatic disease where complete resection is not considered possible or feasible
  • Measurable disease
  • Radiological disease progression during the last 14 months
Show all 18Show fewer
  • The largest metastases should have an uptake of 111In-octreotide that is greater than the uptake in the liver by planar scintigraphy. Metastases that are small, or located centrally, can be evaluated by SPECT to enable a correct estimation of the relative uptake. The majority of the tumor burden must demonstrate an increased uptake for lutetium-treatment to be considered
  • Stable dose of somatostatin analogue for the past 3 months
  • Estimated survival more than 6 months
  • ANC more than 1.5 x 10 9/L
  • Bilirubin less than 1.5 x upper limit of normal
  • GFR more than 50 ml/min.
  • Signed written informed concent
  • Step 2:
  • Continues to fulfill all of the inclusion criteria, and none of the exclusion criteria, from step 1
  • A maintained GFR (less than 40 % decrease compared to baseline AND GFR more than 50 ml/min)
  • The treatment in step 1 have been administered with a maximal interval of 12 weeks
  • Age under 70 years

Who cannot join

  • Step 1:
  • Performance Status ECOG 3-4
  • Proliferation index (Ki67) more than 20 % or more than 20 mitoses/hpf
  • Loco-regional treatment during the last 3 months involving all of the measurable lesions
  • Chemotherapy during the last 3 months, or longer if persisting toxicity exists. Earlier treatment with mTORi or TKI is permitted
  • Other concommitant nephrotoxic treatment
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  • Modifications of the somatostatine dose in the last 3 months
  • Serious heart disease
  • Previous radiotherapy including more than 25 % of active bone marrow volume
  • Pregnancy and lactation
  • Extensive liver metastases (more than 50 % of liver volume)
  • Symptomatic CNS metastases requiring corticosteroid treatment
  • Ongoing treatment with interferon. This treatment should be suspended a minimum of 4 weeks before treatment with 177Lu-DOTA-TATE, or longer if there is persisting signs of toxicity
  • Patients who have another metastatic tumor diagnosis
  • Step 2:
  • Progressive disease since start of study treatment
  • Organ toxicity grade 3-4 during step 1
  • Serious hematological toxicity during previous treatment cycles (ANC less than 0.5 x 10 9 or platelets less than 50.0 x 10 9)
  • Longstanding diabetes (more than 8 years). Patients with a well-controlled diabetes with a history of less than 8 years and a blood pressure less than 130/80 and no albuminuria (albumin/creatinine index)can be included
  • Hypertension, i.e. more than 160/90 (for diabetics more than 130/80). Antihypertensive pharmacological treatment is permitted as long as there is no manifest albuminuria
  • Previous liver embolisation
  • Previous chemotherapy

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Sahlgrenska University Hospital, Department of Oncology

    Gothenburg, 413 45

  • Department of Oncology, Lund University Hospital

    Lund, 221 85

Other trials in Sweden

About this study

Official title: A Multicenter Phase II-Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors

By improved kidney dosimetry including biological effective dose and taking into account potential risk factors (especially for kidney toxicity), it might be possible to give an optimal and personalized treatment with 177Lu-DOTA-TATE to the patient with metastatic neuroendocrine tumor.

Being tested
177Lu-DOTA-TATE
Keywords
Neuroendocrine tumor, Liver metastases, 177Lu-DOTA-TATE, Safety, Kidney dosimetry, Dose escalation, Neuroendocrine tumors, with liver metastases.
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • 177Lu-DOTA-TATEDrug

    177Lu-DOTA-TATE given as intravenous infusion given during 3-5 treatments. Evaluation is performed after every single cycle. Further more, evaluation is made after last cycle, and delivered cumulative dose to kidneys should be 27 Gy.

    Patients with stable disease or partial response, and without pronounced toxicity will continue treatment to a step 2, where additional 3-5 treatment cycles are given, with a cumulative dose to kidneys to 40 Gy.

Study groups in NCT01456078
Study groupRoleWhat they receive
177Lu-DOTA-TATEExperimentalNot described
Receives: Drug: 177Lu-DOTA-TATE

What is being measured

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

  1. Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy

    Measured: 3 months after completed step 1

Secondary outcomes (1)

  1. Objective tumor response after receiving a cumulative BED to the kidneys of 40 +/- 2 Gy as per RECIST v 1.1

    Measured: 3 months after completing step 2 treatment

Timeline

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

  1. First posted20 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionNov 2018
  4. Study completionNov 2018

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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456078
Sponsor's protocol ID
EudraCT number: 2011-000240-16
Acronym
ILUMINET
Status last verified
Sep 2019
First submitted
7 Oct 2011
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • Warfvinge CF, Gustafsson J, Roth D, Tennvall J, Svensson J, Bernhardt P, Akesson A, Wieslander E, Sundlov A, Sjogreen Gleisner K. Relationship Between Absorbed Dose and Response in Neuroendocrine Tumors Treated with [177Lu]Lu-DOTATATE. J Nucl Med. 2024 Jul 1;65(7):1070-1075. doi: 10.2967/jnumed.123.266991.

    PubMed 38724277

  • Sundlov A, Gleisner KS, Tennvall J, Ljungberg M, Warfvinge CF, Holgersson K, Hallqvist A, Bernhardt P, Svensson J. Phase II trial demonstrates the efficacy and safety of individualized, dosimetry-based 177Lu-DOTATATE treatment of NET patients. Eur J Nucl Med Mol Imaging. 2022 Sep;49(11):3830-3840. doi: 10.1007/s00259-022-05786-w. Epub 2022 Apr 22.

    PubMed 35451612

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-DOTA-TATE in people with Neuroendocrine Tumors and Liver Metastases, run by Lund University Hospital at 2 sites in Sweden.

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 18 inclusion and 22 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: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy (time frame: 3 months after completed step 1). 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 NCT01456078, which also lists 2 linked publications.

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 30 Sep 2019.

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