Recurrent or refractory high-risk neuroblastoma
Conditions
Interventions
The following treatment will be administered in cycles of 21 days, totaling 6 cycles.
Day 1: Temozolomide (100 mg/m^2), Irinotecan (50 mg/m^2)
Day 2-5: Temozolomide (100 mg/m^2), Irinotecan (50 mg/m^2
Sponsors
Iehara Tomoko
Nitani Chika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age at the enrollment is 1 year or older. (2) At the diagnosis, the patient is classified as high risk based on the INRG risk classification. Additionally, the patient meets either of the following criteria: (i) pathologically diagnosed with neuroblastoma or ganglioma, or (ii) tumor cells are present in the bone marrow and urinary catecholamine levels are elevated to more than twice the upper normal limit at the time of diagnosis. (3) At the enrollment, the patient meets any of the following criteria: - Experienced distant metastasis recurrence after completion of initial treatment - Experienced progression during initial treatment - Underwent at least four cycles of chemotherapy including two or more anticancer agents containing alkylating agents and platinum-containing compounds, but achieved less than partial response according to INRC criteria (4) The patient meets any of the following criteria: - Has measurable lesions on MRI or CT scans taken within 3 weeks prior to the enrollment - Has evaluable lesions on a 123I-metaiodobenzylguanidine scan taken within 3 weeks prior to the enrollment (5) Has a Karnofsky scale score of 50 or higher (for those over 16 years of age) or a Lansky scale score of 50 or higher (for those 16 years of age or younger) at the enrollment (6) Meets all criteria in blood tests taken within 14 days prior to the enrollment (7) Has a fractional shortening of 27% or higher, or an ejection fraction of 50% or higher on a cardiac ultrasound examination taken within 28 days prior to the enrollment (8) Has obtained written consent from the subject or legal representative at the enrollment
Exclusion criteria
Exclusion criteria: (1) Patients who received irinotecan-temozolomide therapy within 6 weeks prior to the enrollment or who were determined by their attending physician to be refractory to irinotecan-temozolomide therapy after initial recurrence (2) Patients who received chemotherapy other than irinotecan-temozolomide therapy that caused bone marrow suppression within 2 weeks prior to the enrollment (3) Patients who received biological therapy containing anti-GD2 antibodies, retinoid therapy, or other treatments that do not cause bone marrow suppression within 1 week prior to the enrollment. (4) Patients who underwent stem cell transplantation within 6 weeks prior to the enrollment. (5) Patients who received MIBG therapy within 6 weeks prior to the enrollment. (6) Patients who received radiation therapy to the target lesion within 4 weeks prior to the enrollment. However, palliative radiation therapy to non-target lesions is permitted to enroll to this study. (7) Progression during previous anti-GD2 antibody therapy (8) Received systemic steroids within 7 days prior to the enrollment. (9) Enzyme-inducing anticonvulsants such as phenytoin, phenobarbital, sodium valproate, or carbamazepine were administered within 7 days prior to the enrollment. (10) Active concurrent multiple cancers or metachronous multiple cancers with a disease-free period of less than 5 years at the enrollment. (11) Patient who has an infection requiring treatment at the enrollment. (12) Patient who has respiratory failure requiring oxygen administration at the enrollment. (13) Patient who has symptoms of congestive heart failure at the enrollment. (14) Patient who has diarrhea symptoms of Grade 2 or higher at the enrollment. (15) Pregnant or possibly pregnant at the enrollment, or unable to discontinue breastfeeding from the start of treatment drug administration until 120 days after the final administration of the investigational drugs. (16) Unable to use effective contraception during and for at least 6 months after administration of the investigational drugs. (17) Has a psychiatric disorder or psychiatric symptoms at the enrollment, making participation in the trial difficult. (18) History of hypersensitivity to any component of the investigational drugs. (19) Patient who has intestinal paralysis or intestinal obstruction at the enrollment. (20) Patient who has interstitial pneumonia or pulmonary fibrosis at the enrollment. (21) Patient who has a large amount of ascites or pleural effusion at the enrollment. (22) Other conditions deemed inappropriate for participation in this trial by the principal investigator or other relevant parties.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate based on best overall response | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, incidence of adverse events | — |
Contacts
Public ContactHiroshi Miyamoto
FIVERINGS CO.,LTD.
Outcome results
None listed