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

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut Claudius Regaud
• Treatments: Lutetium Lu 177 dotatate; Octreotide; Somatostatin

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 )