Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT04796012
Brief Summary:
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.
Detailed Description:
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 patients and will determine that the therapy is feasible if no more than 2 patients develop a dose-limiting toxicity. Provided that we meet our primary safety endpoint in the feasibility cohort, we will next accrue patients in the RMS efficacy cohort. We will accrue 17 patients in the RMS efficacy cohort. Patients in the feasibility cohort with RMS will be included in this number.
We will determine the objective response rate, duration of response, and progression-free survival for all children with relapsed or refractory solid tumors treated with vincristine, irinotecan, temozolomide, and atezolizumab.
Study:
NCT04796012
Study Brief:
Protocol Section:
NCT04796012