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

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ClinicalTrials.gov Identifier: NCT01456078
Recruitment Status : Recruiting
First Posted : October 20, 2011
Last Update Posted : March 12, 2018
Information provided by (Responsible Party):
Lund University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Liver Metastases Drug: 177Lu-DOTA-TATE Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 177Lu-DOTA-TATE Drug: 177Lu-DOTA-TATE

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.

Primary Outcome Measures :
  1. Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy [ Time Frame: 3 months after completed step 1 ]

Secondary Outcome Measures :
  1. Objective tumor response after receiving a cumulative BED to the kidneys of 40 +/- 2 Gy as per RECIST v 1.1 [ Time Frame: 3 months after completing step 2 treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

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
  • 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

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): NCT01456078

Contact: Jan Tennvall, MD, PhD +46 46 17 75 78 jan.tennvall@med.lu.se
Contact: Charlotte Fogelström, RN +46 46 17 85 61 charlotte.fogelstrom@skane.se

Sahlgrenska University Hospital, Department of Oncology Recruiting
Göteborg, Sweden, 413 45
Contact: Johanna Svensson, MD       johanna.svensson@vgregion.se   
Principal Investigator: Johanna Svensson, MD         
Department of Oncology, Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Jan Tennvall, MD, PhD       jan.tennvall@med.lu.se   
Contact: Charlotte Fogelström, RN       charlotte.fogelstrom@skane.se   
Principal Investigator: Jan Tennvall, MD, PhD         
Sponsors and Collaborators
Lund University Hospital
Principal Investigator: Jan Tennvall, MD, PhD Department of Oncology, Lund University Hospital

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01456078     History of Changes
Other Study ID Numbers: EudraCT number: 2011-000240-16
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by Lund University Hospital:
Neuroendocrine tumor
Liver metastases
Kidney dosimetry
Dose escalation
Neuroendocrine tumors, with liver metastases.

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neoplastic Processes
Pathologic Processes
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents