VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-30
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent

Relapsed or refractory solid tumor after at least one prior course of therapy.

Hodgkin lymphoma or non-Hodgkin lymphoma are not permitted.

Patients with CNS malignancy or asymptomatic CNS metastases may be enrolled, provided all of the following criteria are met.

Disqualifiers

Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment

Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study treatment.

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Vincristine
  • Irinotecan
  • Temozolomide

Treatment groups

23 Participants
are divided into 2 treatment groups