Actively Recruiting
Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
Led by Emory University · Updated on 2026-02-27
55
Participants Needed
5
Research Sites
437 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
P
PeachBowl LegACy Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this study is to improve the 2-year progression-free survival in children with high-risk solid tumors who are administered a maintenance regimen with continuous sirolimus administered on a backbone of metronomic chemotherapy following the completion of "standard" therapy, as compared to high-risk solid tumor patients treated with observation alone following completion of "standard" therapy.
CONDITIONS
Official Title
Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 months and 30 years at enrollment
- Diagnosis of high-risk pediatric extracranial solid tumor in complete remission or with minimal imaging abnormalities after initial therapy or relapse treatment
- Specific tumor types include metastatic or unresectable osteosarcoma, metastatic Ewing or Ewing-like sarcoma, high-risk rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue sarcoma, desmoplastic small round cell tumor, malignant rhabdoid tumor, or other high-risk tumors approved by study chair
- No primary central nervous system tumors or lymphomas
- Histologic confirmation of malignancy at diagnosis or relapse
- Karnofsky score ≥ 50% for patients >16 years or Lansky score ≥ 50% for patients ≤16 years
- Full recovery from acute non-blood-related toxic effects of prior cancer therapy and stable or improving chronic toxic effects
- Adequate bone marrow function with ANC ≥ 750/μL and platelets ≥ 50,000/μL without recent transfusions
- Adequate kidney function by creatinine clearance or GFR ≥ 70 ml/min/1.73 m2 or age/gender-based creatinine values
- Adequate liver function with bilirubin ≤ 2 times upper limit and AST/ALT ≤ 225 U/L
- Serum triglycerides ≤ 300 mg/dL and cholesterol ≤ 300 mg/dL
- Random blood glucose ≤ 1.5 times upper limit for age
- Adequate lung function if clinically indicated; normal oxygen saturation if no symptoms
You will not qualify if you...
- Pregnant or breastfeeding women; pregnancy tests required for post-menarchal girls
- Males and females of reproductive potential must use effective contraception during and for 3 months after treatment
- Receiving corticosteroids must be on stable or decreasing dose for prior 7 days
- Currently taking enzyme-inducing anticonvulsants
- Taking potent CYP3A4 inducers or inhibitors
- Receiving other investigational drugs or anti-cancer agents
- Presence of uncontrolled infection
- Enrolled in other clinical trials for upfront or relapse therapy if in second remission
- Unable to comply with safety monitoring requirements as judged by investigator
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Aflac Cancer & Blood Disorders Centers
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
5
Texas Children's Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kathryn Sutton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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