Phase II clinical trial of dinutuximab in high risk neuroblastoma.

• Conditions: MedDRA version: 16.1Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; High-risk neuroblastoma

• Registration Number: EUCTR2013-004864-69-ES
• Lead Sponsor: Fundació Sant Joan de Deu de Barcelona

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of neuroblastoma as defined by international criteria by histopathology or bone marrow metastases.
2. Neuroblastoma, as defined by risk-related treatment guidelines and the International Neuroblastoma Staging System, stage 4 with (any age) or without (>18 months) MYCN-amplification, or MYCN-amplified neuroblastoma other than stage 1, or high-risk neuroblastoma defined based on the 3-gene molecular profile.
Group 1 patients have neuroblastoma (as defined above) resistant to standard therapy, as evidenced by incomplete response in bone marrow, but no MIBG-avid soft tissue or bone tumor and no progressive disease.
Group 2 patients have no evidence of measurable disease, i.e., are in CR/VGPR from neuroblastoma (as defined above).
3. Signed informed consent indicating awareness of the investigational nature of this program.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Existing severe major organ dysfunction, i.e., renal., cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity >/= grade 3.
2. Progressive disease or MIBG-avid soft tissue/bone tumor.
3. Active life-threatening infection.
4. Inability to comply with protocol requirements.
5. Patient is elegible for SIOP HR-NB-01 protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified