Pediatric refractory malignant solid tumors, Pediatric malignant lymphoma malignant solid tumors,malignant lymphoma
Conditions
Interventions
Sponsors
Ayumu Arakawa
Department of Pediatric Oncology, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pediatric patients with refractory malignant solid tumor or malignant lymphoma corresponding to all of the followings -Progressive, recurrent or metastatic tumor -No indication of curative surgery -Standard therapy is ineffective or inappropriate -No history of allogenic transplant 2)Patients with ALK abnormalities detected with either immunohistochemistry staining, Fluorescence in situ hybridization or gene profiling 3)patients with malignant solid tumor, either or both of the followings are satisfied -In patients with solid tumor, having one or more lesions confirmed by CT or MRI, regardless of measurable or unmeasurable -In patients with solid tumor, having tumor infiltration confirmed by bone-marrow examination -In patients with malignant lymphoma, having one or more lesions confirmed by CT or MRI, regardless of measurable or unmeasurable and not having bone-marrow and/or central nerve system infiltration 4)Aged between 3 and 18 5)Patients who can administer 7mm diameter capsules 6)In patients who are registered to 1st dose in dose determination cohort, body weight with 15 kg or more and less than 35 kg measured within 14 days before registration 7)Performance Status (ECOG) 0, 1, or 2 8)Not having any of the followings: symptomatic brain metastasis, carcinomatous meningitis, or spinal metastasis requiring radiotherapy or surgical intervention 9)Not having any of the followings: pericardial fluid, pleural effusion or ascites requiring treatment 10)Not received anti-cancer drug or other study drug within 28 days before registration 11)No prior treatment with ALK inhibitor (alectinib, crizotinib, ceritinib, brigatinib etc.) 12)Not received operation under general anesthesia within 28 days before registration 13)Leaving the following interval between radiotherapy more than 40 Gy and registration ->=12 weeks: irradiation to any of >=6 spines, whole abdomen, whole lung, whole body, or >= 50% of pelvis ->=6 weeks: irradiation to any of 4 or 5 spines, or >= 25% and =14 days: irradiation to any of =1000 / mm3 -Platelet count>=50000 / mm3 -Total bilirubin= 94% of SpO2 under room air conditions within 14 days before registration 16) Consent to contraception and limited breast-feeding 17) 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)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) 7)Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive 8)Pregnant or breast-feeding women, or women suspected of being pregnant 9)Psychiatric diseases or psychological symptoms interfering with participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of 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
Outcome results
None listed