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.
Title
- Brief Title: 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
Interventions
Drug | Synonyms | Arms |
---|
PRRT with 177Lu-DOTATATE | | PRRT 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
Name | Type | Description | Interventions |
---|
PRRT with 177Lu-DOTATATE | Experimental | | |
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
Last Updated
May 31, 2019