Pediatric malignant solid tumors, Hodgkin lymphoma
Conditions
Interventions
Administration of Nivolumab 3 mg/kg every two weeks as an intravenous infusion
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pediatric malignancy corresponding to any of the followings a.Patients with defined malignant solid tumors with residual tumors after at least two previous chemotherapy regimens 2)Patients with Hodgkin lymphoma with residual tumors after at least two previous chemotherapy regimensIn patients with malignant solid tumor, either or both of the followings are satisfied a.One or more lesions confirmed by CT or MRI, regardless of measurable or unmeasurable b.Having tumor infiltration confirmed by bone-marrow examination 3)In patients with Hodgkin lymphoma, the following all conditions are satisfied a.One or more lesions confirmed by CT or MRI, regardless of measurable or unmeasurable b.One or more FDG-PET-positive lesions c.Not having bone-marrow and/or central nerve system infiltration 4)Aged between 1and 18 in cohort 1. Aged between 1 and 24 in cohort 2 5)Performance Status (ECOG) 0, 1, or 2 6)Not having any of the followings: symptomatic brain metastasis, carcinomatous meningitis, or spinal metastasis requiring radiotherapy or surgical intervention 7)Not having any of the followings: pericardial fluid, pleural effusion or ascites requiring treatment 8)No prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody or other treatment related to T cell regulation 9)Not received systemic corticosteroid at a daily dose of more than 10 mg in prednisolone equivalent or immunosuppressant drug within 14 days before registration 10)Not received anti-cancer drug or other study drug within 28 days before registration 11)Not received operation under general anesthesia within 28 days before registration 12)Leaving a certain interval between radiotherapy and registration 13)Adequate organ function in laboratory tests performed within 14 days before registration 14)>= 94% of SpO2 under room air conditions within 14 days before registration 15)Consent to contraception 16)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years) 2)Infection requiring systemic therapy 3)Active gastrointestinal ulceration 4)Current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings (except for inactive scar or fibrosis associated with radiotherapy) 5)Current or previous severe hypersensitive reaction to medicines 6)Currently active or previously chronic or recurrent auto immune disease (except for type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disorder requiring no systemic therapy, and any auto immune disease expected not to relapse without external factors) 7)HIV antibody-positive, or HTLV-1 antibody-positive, or HBs antigen-positive, or HCV antibody-positive (except for HCV-RNA-negative even if HCV antibody-positive) 8)Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive 9)Pregnant or breast-feeding women, or women suspected of being pregnant 10)Psychiatric diseases or psychological symptoms interfering with participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse effects equivalent to dose-limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Safety Overall response rate Progression-free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactAyumu Arakawa
National Cancer Center Hospital Department of Pediatric Oncology
Outcome results
None listed