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Qarziba for Patients in Relapsed/Refractory High-grade Osteosarcoma

NCT05558280 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-11-18

No results posted yet for this study

Summary

Limited progress has been made in identifying novel targets that may be therapeutic for Osteosarcoma(OS) and there remains an urgent need for the development of new agents that are effective in improving survival. From this perspective, repurposing already proven targets in other tumors may offer new opportunities for OS in children and young adults. Anecdotal evidence of anti-GD2 therapy exists in OS from prior Phase 1 trials that included patients with OS.

Conditions

  • Osteosarcoma in Children

Interventions

DRUG

Dinutuximab beta

The study treatment will be administered with a continuous intravenous infusion at a dose of 14 mg/mq/day, days 1-5, a total of 60 hours (cumulative dose/cycle: 70 mg/mq). Each cycle lasts 28 days.The treatment phase foresees 5 cycles of Dinutuximab Beta.

Sponsors & Collaborators

  • Prof. Franca Fagioli

    lead OTHER

Principal Investigators

  • Franca Fagioli, MD · A.O.U. Città della Salute e della Scienza

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-12-15
Completion
2026-12-15

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558280 on ClinicalTrials.gov