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Monoclonal Antibodies
Atezolizumab + Chemotherapy for Pediatric Solid Cancers
Phase 1 & 2
Recruiting
Led By Matthew Campbell, MD
Research Sponsored by Matthew Campbell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine ≤ 1.5 x ULN for age or creatinine clearance (or radioisotope glomerular filtration rate) ≥ 70 mL/min/1.73 m2
PD-L1(+) status will be defined as staining on ≥1% of tumor cells or ≥1% of stroma
Must not have
Uncontrolled tumor-related pain
Treatment with a live, attenuated vaccine within 30 days prior to initiation of study treatment, or anticipation of the need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24 up to end of study (approximately 48 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of drugs to treat pediatric cancer patients who have relapsed or are unresponsive to other treatments.
Who is the study for?
This trial is for children and young adults aged 6 months to 30 years with relapsed or refractory solid tumors, including rhabdomyosarcoma. Participants must have had at least one prior therapy, meet specific health criteria (like organ function tests), agree to use effective contraception if of childbearing potential, and be able to follow the study protocol.
What is being tested?
The VITAS trial is testing a combination of drugs: vincristine, irinotecan, temozolomide, and atezolizumab in pediatric patients. It's an open-label Phase I/II study which means everyone gets the treatment and both safety and effectiveness are being measured.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, digestive issues like nausea or diarrhea, blood disorders that can affect cell counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine levels or clearance, is within the normal range.
Select...
My cancer shows PD-L1 positive status.
Select...
I am between 6 months and 18 years old.
Select...
I can do most activities but may need help.
Select...
My liver enzymes are within normal limits for my age.
Select...
I can provide a tumor sample and report for PD-L1 testing.
Select...
I have never had bleeding in my brain or spinal cord.
Select...
My cancer has not spread to specific areas of my brain or close to my optic nerve.
Select...
I have never had cancer spread to the lining of my brain and spinal cord.
Select...
My solid tumor cancer came back or didn't respond after my first treatment.
Select...
I am between 6 months and 30 years old.
Select...
I can provide a sample of my tumor for PD-L1 testing.
Select...
My cancer is confirmed to be rhabdomyosarcoma.
Select...
I do not have Hodgkin or non-Hodgkin lymphoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have pain from my cancer that isn't relieved by treatment.
Select...
I have not received a live vaccine within the last 30 days and do not plan to during or within 5 months after treatment.
Select...
I have not used herbal cancer treatments in the last week.
Select...
I have active tuberculosis.
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I frequently need procedures to remove excess fluid from my body.
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I have a history of specific lung conditions or signs of lung inflammation on a recent CT scan.
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I have trouble breathing even when resting or need extra oxygen.
Select...
I have active hepatitis C.
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I haven't had major heart problems or strokes in the last 3 months.
Select...
I do not have any ongoing or untreated serious infections.
Select...
I am currently on medication for hepatitis B.
Select...
I haven't had major surgery in the last 30 days and don't expect any in the next 4 treatment cycles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 24 up to end of study (approximately 48 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24 up to end of study (approximately 48 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Acute Adverse Events (AEs)
Number of participants with Dose-limiting Toxicities (DLTs)
Number of participants with Serious Adverse Events (SAEs)
+1 moreSecondary study objectives
Duration of response
Overall survival (OS)
Progression-free survival (PFS)
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcomaExperimental Treatment4 Interventions
Seventeen (17) participants with RMS, including the six participants from the Feasibility Cohort, will be enrolled. At least 8 of the RMS participants must have a tumor that expresses the protein PD-L1. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
Group II: Feasibility Cohort: Patients with relapsed or refractory solid tumorsExperimental Treatment4 Interventions
Six (6) participants with relapsed or refractory solid tumor will be enrolled. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
2003
Completed Phase 4
~2970
Temozolomide
2010
Completed Phase 3
~1880
Irinotecan
2017
Completed Phase 3
~2590
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Matthew CampbellLead Sponsor
University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,166 Total Patients Enrolled
Matthew Campbell, MDPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe or uncontrolled asthma.My neurological condition has been stable for the last week.I am on a stable or reducing dose of steroids for my CNS condition, approved by the study lead.I've had high-dose chemotherapy and stem-cell therapy within the last 3 months.My kidney function, measured by creatinine levels or clearance, is within the normal range.You have provided written permission to participate in the study.My cancer test used a specific method and was done in a certified lab.I have pain from my cancer that isn't relieved by treatment.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have an autoimmune thyroid condition but am on medication for it.Your blood counts are within normal range without the need for medication or transfusions in the last 7-14 days.I have not received a live vaccine within the last 30 days and do not plan to during or within 5 months after treatment.I have not used herbal cancer treatments in the last week.I have active tuberculosis.I haven't had stem cell or organ transplants, or certain immune therapies, and didn't worsen on irinotecan or temozolomide.I have a skin condition like eczema or psoriasis, but it's mild and well-controlled with weak creams.My cancer shows PD-L1 positive status.I am between 6 months and 18 years old.I can do most activities but may need help.My disease can be evaluated and I may be checked for measurable disease.My bilirubin levels are within the normal range, or I have Gilbert's syndrome with levels ≤ 3 times the normal.My liver enzymes are within normal limits for my age.I do not have an autoimmune disease or immune deficiency.My cancer can be measured or seen on scans, and it has grown despite previous treatments.My tumor is PD-L1 positive.My recent tests show my organs and bone marrow are functioning well.I don't have any health issues that would make it unsafe for me to take a new drug.I am taking antibiotics to prevent infections.I frequently need procedures to remove excess fluid from my body.I have a history of specific lung conditions or signs of lung inflammation on a recent CT scan.I have trouble breathing even when resting or need extra oxygen.I do not have uncontrolled seizures and am on a stable dose of seizure medication that does not strongly affect CYP3A4.I have recovered from previous cancer treatment side effects, except for hair loss or stable conditions needing ongoing treatment.I have active hepatitis C.I haven't had major heart problems or strokes in the last 3 months.My cancer's PD-L1 status is not required but will be tested for research.I can provide a tumor sample and report for PD-L1 testing.My pain medication dose has been stable for at least 2 weeks.I haven't taken any immune-weakening drugs in the last 2 weeks.I've only had short-term immunosuppressants, approved by the study's lead researcher.I am using or will use highly effective birth control during and for 5 months after treatment.I have healed from any biopsy or device placement before starting the study medication.I haven't had chemotherapy or radiotherapy in the last 3 weeks.I do not have any ongoing or untreated serious infections.I will use highly effective birth control and not donate sperm during and for 5 months after treatment.I have never had bleeding in my brain or spinal cord.I am taking steroids for asthma, COPD, low blood pressure, or adrenal issues.I haven't taken strong CYP3A4 or UGT1A1 inhibitors in the last 12 days.I haven't taken long-acting blood cell boosters in the last 2 weeks or short-acting ones in the last week.I haven't taken any long-lasting antibody treatments recently.My cancer has not spread to specific areas of my brain or close to my optic nerve.You are allergic or have a severe reaction to any of the study medications.I have never had cancer spread to the lining of my brain and spinal cord.I am a woman who can still have children.You have participated in another clinical trial or received experimental treatment within the past 21 days.I understand that periodic abstinence and withdrawal are not considered reliable contraception methods for this trial.I haven't had targeted cell therapy in the last 28 days.My recent tests show my organs and bone marrow are functioning well.I have brain cancer or brain metastases but meet specific health criteria.I haven't had brain surgery or brain radiation in the last 30 days.I have a solid tumor that didn't respond to treatment, but not lymphoma, and no severe brain issues.I have had lung scarring from previous radiation treatment.You are able to follow the study rules according to the investigator's opinion.My solid tumor cancer came back or didn't respond after my first treatment.My blood thinner medication dose has been stable.I agree to not have sex or use birth control and not donate sperm.I am between 6 months and 30 years old.I am currently on medication for hepatitis B.I haven't had major surgery in the last 30 days and don't expect any in the next 4 treatment cycles.I can provide a sample of my tumor for PD-L1 testing.My cancer is confirmed to be rhabdomyosarcoma.I have Type 1 diabetes that is managed with insulin.My cancer has grown in an area previously treated with radiation.I can provide a tumor sample for PD-L1 testing.I can receive blood transfusions to meet the trial requirements.To participate in this study, you must use a very effective form of birth control, such as surgery to prevent pregnancy, a hormone-based method that stops ovulation or an intrauterine device that releases hormones or copper.My tumor is PD-L1 positive.I haven't taken cancer drugs that don't affect bone marrow within the last week.I don't have stomach or bowel problems affecting drug absorption.I do not have Hodgkin or non-Hodgkin lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcoma
- Group 2: Feasibility Cohort: Patients with relapsed or refractory solid tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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