VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors (NCT04796012) | Clinical Trial Compass
RecruitingPhase 1/2
VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors
United States23 participantsStarted 2023-04-18
Plain-language 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.
Who can participate
Age range
6 Months – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Must have histologically confirmed rhabdomyosarcoma (RMS) for RMS efficacy cohort.
. Age ≥ 6 months and ≤ 30 years
. Lansky Performance Status (patients \< 16 years old) or Karnofsky Performance Status (patients ≥ 16 years old) ≥ 50
. Ability to comply with the study protocol, in the investigator's judgment
Exclusion criteria
. Pregnancy or breast-feeding:
. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with Dose-limiting Toxicities (DLTs)
Timeframe: Beginning of cycle 3, or 30 days after the second cycle has started, whichever is earlier (each cycle is 21 days)
2
Number of participants with Acute Adverse Events (AEs)
Timeframe: 42 days post treatment.
3
Number of participants with Serious Adverse Events (SAEs)
Timeframe: 48 months
4
Objective response rate (ORR)
Timeframe: Up to 18 weeks post treatment
5
Objective response rate (ORR)
Timeframe: Week 18 up to 24 months post treatment
6
Objective response rate (ORR)
Timeframe: Month 24 up to end of study (approximately 48 months)
Trial details
NCT IDNCT04796012
SponsorUniversity of Texas Southwestern Medical Center
. Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study treatment.
. Medical conditions that are excluded:
. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Guillain-Barré syndrome, multiple sclerosis, or Kawasaki syndrome with the following exceptions:
. Uncontrolled or symptomatic hypercalcemia (ionized calcium \&gt; 1.5 mmol/L, calcium \&gt; 12 mg/dL or corrected serum calcium \&gt; ULN)
. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)