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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 : Completed
First Posted : October 20, 2011
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Tracking Information
First Submitted Date  ICMJE October 7, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date September 30, 2019
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy [ Time Frame: 3 months after completed step 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01456078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
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 ]
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 A Multicenter Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors
Official Title  ICMJE A Multicenter Phase II-Study Evaluating Efficacy and Safety of 177Lu-DOTA-TATE Based on Kidney-Dosimetry in Patients With Disseminated Neuroendocrine Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumors
  • Liver Metastases
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: 177Lu-DOTA-TATE
Intervention: Drug: 177Lu-DOTA-TATE
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2018
Actual Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01456078
Other Study ID Numbers  ICMJE EudraCT number: 2011-000240-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lund University Hospital
Study Sponsor  ICMJE Lund University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Tennvall, MD, PhD Department of Oncology, Lund University Hospital
PRS Account Lund University Hospital
Verification Date September 2019

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