Iodine I 131 Metaiodobenzylguanidine and a Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory High-Risk Neuroblastoma

Titre officiel

A Phase I Study Of UltratraceTM Iobenguane I 131 In Patients With Relapsed/Refractory High-Risk Neuroblastoma

Sommaire:

Les médicaments radioactifs, tels que la méta-iodobenzylguanidine (MIBG) marquée à l’iode 131, pourraient permettre d’irradier directement les cellules tumorales sans léser les cellules normales. Une autogreffe de moelle osseuse ou de cellules souches périphériques pourrait permettre de remplacer les cellules hématopoïétiques qui ont été détruites par la MIBG marquée à l’iode 131.

Cet essai de phase I vise à déterminer les effets secondaires de la MIBG marquée à l’iode 131 ainsi que la meilleure dose de ce médicament à utiliser lorsque son administration est suivie d’une greffe de cellules souches dans le traitement des jeunes patients atteints d’un neuroblastome à risque élevé récidivant ou réfractaire.

Description de l'essai

Primary Outcome:

• Maximum tolerated dose

• Toxicity
• Estimation of radiation absorbed doses to measurable lesions
• Objective tumour response after treatment
• Dose response after treatment
• Quality of life

OBJECTIVES:

Primary

• To establish the maximum tolerated dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) in patients with relapsed/refractory high-risk neuroblastoma

Secondary

• To describe toxicity following treatment with ^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma.
• To estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following a 0.1 mCi/kg [3.7 MBq/kg] (minimum dose of 1.0 mCi [37 MBq] but not to exceed 5.0 mCi [185 MBq]) intravenous administration of ^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma.
• To describe, within the confines of a phase I trial, objective tumour response following treatment with ^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma.
• To explore dose-response following treatment with ^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma.
• To explore quality of life assessment following treatment with ^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma.

• Dosimetry: Patients receive a dosimetric dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 2-3 minutes. Patients then undergo 2 or 3 MIBG scans within 5 days of the dosimetry dose to assess biodistribution and tumour uptake. Patients with normal tumour uptake and biodistribution proceed to treatment.
• Treatment: Within 1-4 weeks of the dosimetric dose, patients with normal tumour uptake and biodistribution receive a therapeutic dose of ^131I-MIBG IV over 1 hour on day 0 and undergo MIBG scan on day 7. Patients then proceed to allogeneic stem cell infusion.
• Allogeneic stem cell infusion: Patients receive an infusion of autologous stem cells from peripheral blood or bone marrow on day 14. Patients with an ANC of < 500/µl at any point after autologous stem cell infusion receive filgrastim (G-CSF) IV or subcutaneously once daily until ANC is > 2,000/µl. Patients complete a quality of life questionnaire at baseline and then at day 60. After completion of study treatment, patients are followed at day 60 and periodically thereafter.

Voir cet essai sur ClinicalTrials.gov