International Phase II Studies of131I-mIBG in combination with topotecanand peripheral blood stem cell rescue for(A) primary resistant high risk neuroblastoma and(B) relapsed stage 4 neuroblastoma - mIBG Topoteca

Phase 1

• Conditions: euroblastoma

• Registration Number: EUCTR2005-002089-13-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-12-31
• Study Start: 2006-04-27
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1)Is aged 1 year or over and has high-risk neuroblastoma (INSS Stage 4, or Stage 2 or 3 with MycN amplification)
2)Is enrolled on the SIOP-Europe high-risk neuroblastoma study or has been treated according to that protocol, or has been treated according to a similar protocol
3)Fails to achieve satisfactory remission with induction chemotherapy (defined as >50% reduction or more than 3 positive sites on mIBG scintigraphy, or persistent cytomorphological positive disease in bone marrow aspirates or trephine biopsies) at day 80 after COJEC induction, (or progressive disease at an earlier date necessitating a change to treatment)
4)has mIBG positive disease on diagnostic scintigraphy at the time of consideration of entry to this study
5)is being treated at, or clinicians and parents (or the patient in the case of an adult) are willing for the patient to be referred to, a centre participating in this study
6)has parents who are willing to consider entry into this study and who give informed consent in writing or, in the case of a competent adult, the patient may give informed consent on their own.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Not meeting any of the inclusion criteria

Study & Design

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