High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)

Launched by ST. ANNA KINDERKREBSFORSCHUNG · Oct 10, 2012

Keywords

ClinConnect Summary

The High Risk Neuroblastoma Study 1.8, conducted by the European SIOP Neuroblastoma Group (SIOPEN), is testing a new treatment approach for children and young adults diagnosed with high-risk neuroblastoma, a serious type of cancer that affects the nervous system. The study involves a series of intensive treatments, starting with chemotherapy to reduce the tumor, followed by surgery to remove it, and then additional therapies including radiation and immunotherapy. Participants may receive a specific antibody treatment (ch14.18/CHO) with or without another medication (IL-2) to help their immune system fight the cancer.

To be eligible for this trial, participants must be under 21 years old and have a confirmed diagnosis of high-risk neuroblastoma. This includes certain stages of the disease, particularly those with specific genetic markers. Patients who have had limited previous treatment may also qualify. Throughout the trial, participants will be closely monitored for five years to evaluate the effectiveness of the treatments. If you choose to participate, you will be part of a randomized study, meaning you may receive one of several treatment options, and you will need to provide consent, which includes agreement from a parent or guardian if you are under 18.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS).
• • Age below 21 years.
• * High risk neuroblastoma defined as either:
• • 1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or
• • 2. INSS stage 4 without MYCN amplification aged \> 12 months at diagnosis
• • Patients who have received no previous chemotherapy except for one cycle of etoposide and carboplatin (VP16/Carbo). In this situation patients will receive Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the first cycle VP16/Carbo (etoposide / carboplatin).
• • Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met.
• • Tumour cell material available for determination of biological prognostic factors.
• • Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
• • Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis.
• • Provisional follow up of 5 years.
• • National and local ethical committee approval.
• Exclusion Criteria:
• • Any negative answer concerning the inclusion criteria of the study
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