University of Texas Southwestern Medical Center
This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.
In this study, we will test the combination of atezolizumab with chemotherapy for relapsed solid tumors in childhood. The combination of vincristine, irinotecan, temozolomide, and atezolizumab has not been tested. Thus, the trial will have two sequential cohorts: (1) a feasibility cohort, and (2) a rhabdomyosarcoma (RMS) efficacy cohort. In the first cohort, we will determine the feasibility of administering vincristine, irinotecan, temozolomide, and atezolizumab simultaneously in children with relapsed or refractory solid tumors, regardless of histology or PD-L1 status. We will accrue 6 patie…
Inclusion Criteria: 1. Signed informed consent 2. Relapsed or refractory solid tumor after at least one prior course of therapy. 1. Hodgkin lymphoma or non-Hodgkin lymphoma are not permitted. 2. Patients with CNS malignancy or asymptomatic CNS metastases may be enrolled, provided all of the following criteria are met. * No metastatic or primary disease affecting the brainstem, midbrain, pons, or cerebellum, or within 10 mm of optic nerve * No history of leptomeningeal disease * No history of intracranial or spinal cord hemorrhage * No evidence of progression of…
Feasibility and RMS Cohorts: Administered at 15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle
Feasibility and RMS Cohorts: Administered at 1.5 mg/m\^2 (max 2 mg) IV on Day 1 of each 21-day cycle
Feasibility and RMS Cohorts: Administered at 50 mg/m2 IV on Days 1-5 of each 21-day cycle
Feasibility and RMS Cohorts: Administered at 100 mg/m\^2 (max 200 mg) IV or PO 1 hour before irinotecan injection on Days 1-5 if each 21-day cycle