A Phase I Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a multicenter, open label phase I dose escalation trial designed to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE in children with refractory or recurrent neuroblastoma. 177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart. The duration of study participation of each patient will be 5 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed diagnosis of neuroblastoma (patients can be included whatever the results of the 123ImIBG scan).

• Recurrent or refractory neuroblastoma following at least two prior standard treatment regimen.

• Positive 68Ga-DOTATOC PET within 6 weeks prior to day 1 dosing. Note: PET positivity is visually defined as follow: uptake should be equivalent or higher than the liver uptake for all lesions identified by conventional neuroblastoma imaging working.

• Patient for whom no effective conventional therapy exists.

• a) For dose levels 1 (80 MBq/kg) \& 2 (100 MBq/kg): Age \> 1 year and \< 18 years at the time of enrollment into the study. b) For dose level 3 (120 MBq/kg):

• \- If at least one patient \< 2 years old has been enrolled in one of the previous dose levels (80 or 100 MBq/kg): Age \> 1 year and \< 18 years at the time of enrollment into the study.

• \- If no patient \< 2 years old was enrolled in one of the previous dose levels (80 or 100 MBq/kg): Age ≥ 2 years and \< 18 years at the time of enrollment into the study.

• Life expectancy greater than 3 months.

• Adequate performance Status defined as: Karnofsky or Lansky Play Performance Scale ≥ 50% (depending on patient's age).

• Adequate recovery from major surgery prior to receiving study treatment.

• Patients must have recovered (to CTCAE grade 1 or baseline) from any acute toxicity resulting from any prior anti-cancer treatment (except alopecia and ototoxicity).

⁃ Patient must have adequate organ function as defined by the following values (within 6 weeks of first dose of study treatment):

∙ Bone marrow function:

∙ If no bone marrow disease:

∙ Platelets ≥ 100 x 109/L (unsupported for 72 hours) Absolute Neutrophil Count (ANC) ≥ 0.75 x 109/L Hemoglobin \> 7.5 g/dL (transfusions are allowed)

∙ In case of bone marrow disease:

∙ Platelets ≥ 75 x109/L (unsupported for 72 hours) ANC ≥0.5 x 109/L Hemoglobin \> 7.5 g/dL (transfusions are allowed)

‣ Renal function:

∙ Serum creatinine ≤1.5 ULN for age; if higher, a calculated Glomerular Filtration Rate (GFR) (2009 Schwartz formula\*) must be ≥ 60 ml/min/1.73 m2

∙ \* eGFR (mL/min/1,73 m²) = height (cm) x 36,5 / serum creatinine (µmol/L)

‣ Liver function:

∙ AST and ALT ≤2.5 ULN and total bilirubin ≤1.5 ULN. In case of liver metastases, AST and ALT ≤5 ULN and total bilirubin ≤2.5 ULN

‣ Cardiac function: Shortening fraction ≥ 28% or ejection fraction ≥ 55% by echocardiogram, with no clinical congestive heart failure associated. Normal pulmonary artery pressure.

⁃ Patient assent and patients/parent(s)/legal guardian(s) written informed consent that is consistent with French law and ICH-GCP guidelines.

⁃ Patients with reproductive potential (girls post menarche and males after 1st ejaculation) and sexually active must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 7 months (for females) or 4 months (for males) after completion of study drug therapy (in accordance with CTFG guidelines).

⁃ Patient affiliated to a Social Health Insurance in France.

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Besançon
RECRUITING
Besançon
CHU Pellegrin
RECRUITING
Bordeaux
CHU Dijon
RECRUITING
Dijon
CHU de Grenoble
RECRUITING
Grenoble
Centre Oscar Lambret
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Hopital Arnaud de Villeneuve
RECRUITING
Montpellier
CHU Nancy
RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
CHU Reims
RECRUITING
Reims
CHU Strasbourg
RECRUITING
Strasbourg
CHU de Toulouse - Hôpital des enfants
RECRUITING
Toulouse
IUCT-O
RECRUITING
Toulouse
Contact Information
Primary
Frédéric COURBON
Courbon.frederic@iuct-oncopole.fr
+33 5 31 15 55 26
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2026-09
Participants
Target number of participants: 18
Treatments
Experimental: PRRT with 177Lu-DOTATATE
Sponsors
Leads: Institut Claudius Regaud
Collaborators: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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