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Alkylating agent

Sirolimus + Chemotherapy for High-Risk Pediatric Cancers (AflacST1903 Trial)

Phase 2
Recruiting
Led By Kathryn Sutton, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky ≥ 50% for subjects > 16 years of age and Lansky ≥ 50% for subjects ≤ 16 years of age.
Adequate renal function defined as creatinine clearance or radioisotope glomerular filtration rate (GFR) 70ml/min/1.73 m2 or serum creatinine based on age/gender values derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

AflacST1903 Trial Summary

This trial is testing whether a maintenance regimen of continuous sirolimus and metronomic chemotherapy can improve the 2-year progression-free survival in children with high-risk solid tumors, as compared to observation alone following completion of "standard" therapy.

Who is the study for?
Children and young adults aged 1 to 30 with high-risk solid tumors, such as osteosarcoma or Ewing sarcoma, who have completed standard therapy and are in remission. They must have good performance status, adequate organ function (liver, kidney), normal blood sugar levels, not be pregnant or breastfeeding, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing whether a maintenance regimen of sirolimus combined with low-dose chemotherapy can improve the progression-free survival for children with high-risk solid tumors compared to just observation after completing standard therapy.See study design
What are the potential side effects?
Sirolimus may cause mouth sores, increased risk of infection, abnormal blood tests affecting kidneys or liver; cyclophosphamide might lead to hair loss, bladder irritation; celecoxib could result in stomach upset; etoposide may bring about low blood counts increasing infection risk.

AflacST1903 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly able to care for myself and carry out daily activities.
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My kidney function is good based on tests.
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My child's cancer is in remission or nearly clear after initial treatment.
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I have a specific type of advanced sarcoma or tumor.
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My liver tests are within the required range.
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I have recovered from previous cancer treatments and my blood counts are within required ranges.
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I am between 12 months and 30 years old.
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My cancer is in complete remission or shows minimal signs on scans.
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My cancer is not a primary brain tumor or lymphoma.
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My blood sugar levels are within the normal range for my age.
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My cancer outside the brain has returned and is in remission again after treatment.

AflacST1903 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Two-year progression-free survival in patients with high-risk solid tumors
Secondary outcome measures
Median progression-free survival of children with high-risk solid tumors
Median progression-free survival of children with recurrent solid tumors in second complete remission
Number of cases of severe toxicities
+3 more

Side effects data

From 2008 Phase 4 trial • 293 Patients • NCT00118742
29%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Anaemia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Jaundice
5%
Renal Failure
5%
Muscle Spasms
5%
Decreased Appetite
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Myalgia
3%
Pleural Effusion
3%
Hyperlipidaemia
3%
Thrombocytopenia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Sepsis
2%
Pneumonia
2%
Hypokalaemia
1%
Cerebral Haemorrhage
1%
Gastritis
1%
Urinary Retention
1%
Abdominal Hernia
1%
Multi-Organ Failure
1%
Ventricular Tachycardia
1%
Renal Failure Acute
1%
Non-Small Cell Lung Cancer Metastatic
1%
Benign Prostatic Hyperplasia
1%
Hypoglycaemia
1%
Crohn's Disease
1%
Clostridium Difficile Colitis
1%
Hepatic Neoplasm Malignant
1%
Hepatic Failure
1%
Chest Pain
1%
Blood Alkaline Phosphatase Increased
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Gastrointestinal Haemorrhage
1%
Cardiac Failure Congestive
1%
Hepatic Artery Stenosis
1%
Portal Vein Thrombosis
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Gastrointestinal Tract Adenoma
1%
Febrile Neutropenia
1%
Encephalopathy
1%
Atrial Flutter
1%
Blood Glucose Increased
1%
Transplant Rejection
1%
Confusional State
1%
Spinal Osteoarthritis
1%
Hypercholesterolaemia
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus

AflacST1903 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Maintenance Chemotherapy RegimenExperimental Treatment4 Interventions
Participants with metastatic osteosarcoma, metastatic Ewing sarcoma, high-risk rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), desmoplastic small round cell tumor (DSRCT), and malignant rhabdoid tumor (MRT) in first complete remission (cohort 1) or participants with recurrent solid tumors (any histology) in second complete remission (cohort 2), receiving a maintenance chemotherapy regimen administered as a 12-month course of continuous sirolimus with celecoxib and low-dose oral etoposide alternating every 21 days with low-dose oral cyclophosphamide following the completion of "standard" therapy.
Group II: Historical Control Cohort Receiving Standard TherapyActive Control1 Intervention
This study arm is a historical control cohort of patients matched with cohort 1 on diagnosis, age, metastatic site, and date of diagnosis. The matched historical controls will be obtained from the same treating institution as the corresponding case to account for institutional differences in treatment and supportive care. Patients in the historical control cohort received standard therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved
Cyclophosphamide
1995
Completed Phase 3
~3770
Celecoxib
2019
Completed Phase 4
~1740
Etoposide
FDA approved

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,646 Total Patients Enrolled
PeachBowl LegACy FundUNKNOWN
Kathryn Sutton, MDPrincipal InvestigatorEmory University

Media Library

Cyclophosphamide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT04469530 — Phase 2
Solid Tumors Research Study Groups: Maintenance Chemotherapy Regimen, Historical Control Cohort Receiving Standard Therapy
Solid Tumors Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04469530 — Phase 2
Cyclophosphamide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04469530 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals welcome to partake in this trial?

"This medical trial only accepts participants between 1 and 30 years of age. According to clinicaltrials.gov, there are 690 studies that cater to minors while 3248 research activities center around seniors approaching their twilight years."

Answered by AI

What afflictions is SIROLIMUS primarily employed to address?

"The drug SIROLIMUS is a frequent treatment for lung cancer, as well as small cell lung cancer (SCLC), organ transplantation, and multiple sclerosis."

Answered by AI

What are the ultimate aims of this trial?

"This trial, which will span roughly two years of evaluation, seeks to determine the number of 2-year progression-free survivors. Secondary objectives include assessing Median progression-free survival of children on a maintenance regimen with sirolimus orally once daily in combination with metronomic chemotherapy compared to observation alone; determining Median progression-free survival in children that take continuous sirolimus orally and alternate between celecoxib and etoposide every 21 days alongside cyclophosphamide versus observational control groups; and Two-year overall survival for all prospectively enrolled participants (those belonging to cohorts 1 and 2)."

Answered by AI

Is SIROLIMUS a safe pharmaceutical for patient use?

"Analyses conducted by the research team at Power indicates that SIROLIMUS is a safe intervention, receiving a score of 2. This rating is warranted as this particular trial sits in phase two, meaning safety has been partially established but there remains no evidence supporting its efficacy."

Answered by AI

Are there any opportunities to volunteer for this research project at present?

"Per information found on clinicaltrials.gov, enrollment for this trial is ongoing. It was first announced in September 2020 and last updated February 2022."

Answered by AI

What is the scope of enrolment of this research project?

"Fifty individuals who meet the eligibility requirements have been asked to participate in this trial, with locations available at Washington University School of Medicine and Aflac Cancer & Blood Disorders Centers."

Answered by AI

What other examinations have been conducted concerning SIROLIMUS?

"SIROLIMUS was originally researched in 1997 at City of Hope Comprehensive Cancer Center. After that, 1839 completed studies have been conducted and 1120 are currently being actively recruited for across the United States, with a considerable number taking place in Saint Louis, Missouri."

Answered by AI

How many medical facilities have implemented this experiment?

"This study is being conducted from the Washington University School of Medicine, Aflac Cancer & Blood Disorders Centers and Children's Healthcare of Atlanta with 5 additional sites."

Answered by AI

Is eligibility for this clinical trial open to me?

"This trial is including 50 people with tumorous growths aged between 1 year and 30 years. Critical requirements include: participants must be 12 months to 30 years old, have high-risk malignant extracranial solid tumors or recurrent extracranial solid tumor in second complete remission following completion of initial relapse regimen; exhibiting Karnofsky ≥50% for those over 16 and Lansky ≥50% for younger patients; fully recovered from the acute non-hematologic toxic effects of all prior anti-cancer therapy, with chronic non-hematologic toxic effects improved to a minimum grade 2 level and stabilized on their current management plan."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
Kathryn S. Sutton 2020. "Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04469530.
~14 spots leftby Sep 2025
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