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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

NCT03966651

Description:

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.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 15 TETE 04
  • NCT ID: NCT03966651

Conditions

  • Neuroblastoma

Interventions

DrugSynonymsArms
PRRT with 177Lu-DOTATATEPRRT with 177Lu-DOTATATE

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PRRT with 177Lu-DOTATATEExperimental
  • PRRT with 177Lu-DOTATATE

Eligibility 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 )
      
Maximum Eligible Age:18 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:The Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE
Time Frame:6 weeks for each patient
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Safety will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events
Time Frame:3 months for each patient
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Institut Claudius Regaud

Trial Keywords

  • PRRT (Peptide Receptor Radionuclide Therapy)
  • 177Lu-DOTATATE

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