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Safety Evaluation of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate for Refractory or Recurrent Metastatic Neuroblastoma Expressing Somatostatin Receptors (NEUROBLU 02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03966651
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Study Description
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Brief Summary:

This multicentric, prospective study aime to determine the Maximum Tolerated Dose (MTD) of 2 intravenous injections of 177Lu-DOTA0-Tyr3-Octreotate (177Lu-DOTATATE) administered at 6 weeks apart in children with metastatic progressive neuroblastoma.

The duration of study participation of each patient will be 3 months.


Condition or disease Intervention/treatment Phase
Neuroblastoma Drug: PRRT with 177Lu-DOTATATE Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE I Clinical Study: Safety Evaluation of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate for Refractory or Recurrent Metastatic Neuroblastoma Expressing Somatostatin Receptors
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: PRRT with 177Lu-DOTATATE Drug: PRRT with 177Lu-DOTATATE
Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.


Outcome Measures
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Primary Outcome Measures :
  1. The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE [ Time Frame: 6 weeks for each patient ]

Secondary Outcome Measures :
  1. Safety will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: 3 months for each patient ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of neuroblastoma
  2. Must have recurrent or refractory metastatic neuroblastoma following at least two prior standard treatment regimen and must have no effective conventional therapy existing
  3. Aged between > 1 to 18 years
  4. Life expectancy greater than 3 months
  5. Must have adequate organ function, bone marrow, liver and renal function
  6. Patient assent and parent(s)/legal guardian(s) written informed consent that is consistent with local law and ICH-GCP guidelines

Exclusion Criteria:

  1. Chemotherapy within 4 weeks prior to the start of study treatment
  2. High dose chemotherapy with stem cell transplantation within 3 months prior biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  3. Radiotherapy within 30 days before starting study treatment

  4. Prior external beam radiation (EBR) therapy

    • to more than 25% of the bone marrow
    • to both kidneys (scatter doses of < 0.5 Gy to a single kidney or radiation to <50% of a single kidney )
Contacts and Locations
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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): NCT03966651


Contacts
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Contact: Frédéric COURBON +33 5 31 15 55 26 Courbon.frederic@iuct-oncopole.fr

Locations
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France
IUCT-O
Toulouse, France
Contact: Frédéric COURBON    +33 5 31 15 55 26    Courbon.frederic@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud
More Information
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03966651    
Other Study ID Numbers: 15 TETE 04
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
PRRT (Peptide Receptor Radionuclide Therapy)
177Lu-DOTATATE
Additional relevant MeSH terms:
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Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lutetium Lu 177 dotatate
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action