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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lund University Hospital
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT01456078
First received: October 7, 2011
Last updated: November 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Neuroendocrine Tumors
Liver Metastases
Drug: 177Lu-DOTA-TATE
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy [ Time Frame: 3 months after completed step 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456078

Contacts
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

Locations
Sweden
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
Investigators
Principal Investigator: Jan Tennvall, MD, PhD Department of Oncology, Lund University Hospital
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT01456078     History of Changes
Other Study ID Numbers: EudraCT number: 2011-000240-16
Study First Received: October 7, 2011
Last Updated: November 3, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Lund University Hospital:
Neuroendocrine tumor
Liver metastases
177Lu-DOTA-TATE
Safety
Kidney dosimetry
Dose escalation
Neuroendocrine tumors, with liver metastases.

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neuroendocrine Tumors
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Processes
Neuroectodermal Tumors
Pathologic Processes
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014