High-risk neuroblastoma
Conditions
Interventions
Tandem autologous peripheral blood stem cell transplantation and anti-GD2 antibody therapy
Sponsors
Takagi Masatoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age The patient's age at the time of diagnosis (date of examination for histological diagnosis) is between 180 days and 18 years and 0 days of age. (2) Histological and genetic diagnosis Histopathological diagnosis of neuroblastoma or ganglioblastoma is made by open biopsy of the primary lesion or metastases, or by bone marrow findings. However, cases with elevated urinary VMA/HVA and tumor cells in the bone marrow may be registered pending pathologic diagnosis of the primary tumor. MYCN amplification and 11q deletion of tumor cells are searched for in the central diagnosis. (3) Stage, prognostic factors, and risk classification This group is judged to be high-risk by INRG risk classification. At the time of inclusion, the following conditions are met, namely. (i) Stage L1, L2, and confirmed MYCN amplification (ii) Stage M for more than 18 months (more than 547 days) (iii) Stage M for less than 18 months (less than 547 days) and MYCN amplification is confirmed. (iv) Stage MS with MYCN amplification or 11q deletion (4) Untreated cases with first-episode disease. However, one course of chemotherapy is acceptable for patients with stage L1, L2, stage M less than 18 months (less than 547 days), and stage MS (cases (3)-1), 3), and 4). (5) Organ damage There must be no serious organ damage that would interfere with study treatment in this study. (i) Patients must be 16 years of age or older and have a Karnofsky scale of 30 or higher, or 15 years of age or younger and have a Lansky scale of 30 or higher. (ii) Hematopoietic function: White blood cell count >_ 2,000/mm3. (iii) Liver function: ALT less than 300 IU/L and total bilirubin less than 2.0 mg/dL. However, this restriction does not apply when the total bilirubin level is considered to be elevated due to constitutional jaundice. (iv) Renal function: Serum creatinine must be below the following age-specific serum creatinine reference values. Under 5 years of age 0.8 mg/dL Age 5 years and above but under 10 years 1.2 mg/dL 10 to 18 years of age 1.5 mg/dL (v) Cardiac function: No cardiac disease requiring treatment. (6) Infectious diseases No active infection. (7) Written consent Written consent to participate in the study must have been obtained from the individual and his/her surrogate or surrogate. Efforts should also be made to obtain assent by providing the individual with explanations appropriate to his/her ability to understand.
Exclusion criteria
Exclusion criteria: (1) When the following 1) and 2) are found with regard to stage, prognostic factors and risk classification (1) Stage M at diagnosis less than 18 months (less than 547 days) and found to have no MYCN gene amplification (ii) found to have no MYCN gene amplification or 11q deletion in stage MS at diagnosis (both of which will be excluded after registration) (2) Active overlapping cancers (simultaneous overlapping cancers and iatrogenic overlapping cancers with a disease-free interval of 5 years or less) (3) Pregnant women, women who may be pregnant or breastfeeding (4) Women with psychosis or concomitant psychiatric symptoms that would make participation in this study difficult (5) Complicated with other illnesses that are expected to make it difficult to tolerate the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Three-year overall survival rate 5-year overall survival and progression-free survival Remission induction rate Cumulative relapse rate Adverse event rate Frequency of long-term complications tumor resection ratio, rate of surgical complications in the total or partial resection group, prognosis and local recurrence rate in the total or partial resection group | — |
Contacts
Public ContactMasatoshi Takagi
Institute of Science Tokyo Hospital
Outcome results
None listed