NCT04796012 · University of Texas Southwestern Medical Center
VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
What this study is about
This trial is a multi-center, non-randomly assigned, where both patients and doctors know the treatment given Phase I/II study evaluating the feasibility and effectiveness of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.
View original scientific description
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.
Interventions
DRUG
Atezolizumab
Feasibility and RMS Cohorts: Administered at 15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle
DRUG
Vincristine
Feasibility and RMS Cohorts: Administered at 1.5 mg/m\^2 (max 2 mg) IV on Day 1 of each 21-day cycle
DRUG
Irinotecan
Feasibility and RMS Cohorts: Administered at 50 mg/m2 IV on Days 1-5 of each 21-day cycle
DRUG
Temozolomide
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
Primary outcome measures
Number of participants with Dose-limiting Toxicities (DLTs)
Time frame: Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days)
DLT is defined as any event that is possibly, probably, or definitely attributable to the treatment regimen and exceeds the protocol defined threshold for severity
Number of participants with Acute Adverse Events (AEs)
Time frame: 42 days post treatment.
AE is defined as any untoward or unfavorable medical occurrence in a human research study participant, including any abnormal sign, symptom, clinical event, or disease, temporally associated with the subject's participation in the research, whether or not it is considered related to the subject's participation in the research. AEs will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE. Acute AEs are events occurring in the time period from the signing of the informed consent, through 42 days post treatment.
Number of participants with Serious Adverse Events (SAEs)
Time frame: 48 months
SAEs are those events, occurring at any dose, which meets any of the following criteria: 1) results in death, 2) is life-threatening, 3) results in inpatient hospitalization or prolongation of existing hospitalization, 4) results in a persistent or significant disability/incapacity, 5) results in a congenital anomly/birth defect in a neonate/infant born to a mother exposed to the IMP; or 6) based upon appropriate medical judgement, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. SAE determination does not require the event to be related to the research. SAEs will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Serious adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE.
Objective response rate (ORR)
Time frame: Up to 18 weeks post treatment
ORR is the percentage of participants whose confirmed best overall response was either a partial response (PR) or a complete response (CR) based upon independent review and per RECIST v1.1, modified INRC, or RANO criteria as appropriate.
Objective response rate (ORR)
Time frame: Week 18 up to 24 months post treatment
ORR is the percentage of participants whose confirmed best overall response was either a partial response (PR) or a complete response (CR) based upon independent review and per RECIST v1.1, modified INRC, or RANO criteria as appropriate.
Objective response rate (ORR)
Time frame: Month 24 up to end of study (approximately 48 months)
ORR is the percentage of participants whose confirmed best overall response was either a partial response (PR) or a complete response (CR) based upon independent review and per RECIST v1.1, modified INRC, or RANO criteria as appropriate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 neurologic deficit, in the investigator's judgment, within 7 days prior to initiation of study medications. 3. Must have histologically confirmed rhabdomyosarcoma (RMS) for RMS efficacy cohort. 3. Age ≥ 6 months and ≤ 30 years 4. Lansky Performance Status (patients \< 16 years old) or Karnofsky Performance Status (patients ≥ 16 years old) ≥ 50 5. Ability to comply with the study protocol, in t
Where
- Chicago, Illinois
- Boston, Massachusetts
- Cincinnati, Ohio
- Philadelphia, Pennsylvania
- Dallas, Texas
- Houston, Texas
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations