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RECRUITING Phase 2

Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors

NCT04469530 · View on ClinicalTrials.gov ↗

Study Summary

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 Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Sirolimus
  • DRUG Etoposide
  • DRUG Celecoxib

Study Locations (5)

Georgia

  • Aflac Cancer & Blood Disorders Centers — Atlanta
  • Children's Healthcare of Atlanta — Atlanta

Missouri

  • Washington University School of Medicine — St Louis

Pennsylvania

  • Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) — Pittsburgh

Texas

  • Texas Children's Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2020-09-16
Est. Completion 2029-02
Phase Phase 2

Sponsor

Emory University

1,434 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04469530

The ClinicalTrials.gov registry entry for NCT04469530 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,434 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04469530 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Georgia, Missouri, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04469530 about?

NCT04469530 is a clinical study titled "Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors". 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...

What is the current status of trial NCT04469530?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2020-09-16. Estimated completion is 2029-02.

What conditions does trial NCT04469530 study?

This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04469530?

The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG), Etoposide (DRUG), Celecoxib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04469530?

This trial is sponsored by Emory University, which has 1,434 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04469530 being conducted?

This trial has 5 study locations across Georgia, Missouri, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial