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

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

Study Description
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 31, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE [ Time Frame: 6 weeks for each patient ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		Safety will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: 3 months for each patient ]
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 Safety Evaluation of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate for Refractory or Recurrent Metastatic Neuroblastoma Expressing Somatostatin Receptors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroblastoma
Intervention  ICMJE Drug: PRRT with 177Lu-DOTATATE
Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.
Study Arms  ICMJE Experimental: PRRT with 177Lu-DOTATATE
Intervention: Drug: PRRT with 177Lu-DOTATATE
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 )
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Frédéric COURBON +33 5 31 15 55 26 Courbon.frederic@iuct-oncopole.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966651
Other Study ID Numbers  ICMJE 15 TETE 04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut Claudius Regaud
Verification Date May 2019

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

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