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NCT04469530 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Solid Tumor, sponsored by Emory University.

Recruiting
Registry status
Phase 2
Development phase
55
Enrollment target
5
Study locations

NCT04469530: Recruiting Phase 2 study of Solid Tumor, sponsored by Emory University.

NCT04469530 is a Phase 2 study of Solid Tumor that is actively recruiting participants, run by Emory University. The registered enrollment target is 55 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (75% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04469530, a Phase 2 study of Solid Tumor, is actively recruiting participants, sponsored by Emory University.

RECRUITING
Registry status
Phase 2
Development phase
55 participants
Enrollment target
5
Study locations

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.

Primary Outcome

Two-year progression-free survival in patients with high-risk solid tumors who complete a 12- month course of maintenance chemotherapy with daily sirolimus and twice daily celecoxib on a backbone of low-dose oral metronomic chemotherapy following completion of "standard" therapy as compared to a historical cohort of matched patients treated with observation only 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
Emory University

1,208 total trials

What NCT04469530 shows while recruiting

NCT04469530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (75% lower).

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.

NCT04469530 lists 5 locations in 4 states (Georgia, Missouri, Pennsylvania).

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.

What interventions are being tested in trial NCT04469530?

The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG), Etoposide (DRUG), Celecoxib (DRUG).

Who is sponsoring clinical trial NCT04469530?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04469530's enrollment target sits among peer trials

55 115th of 196 higher than 81 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04469530, the US trial registry maintained by the National Library of Medicine. NCT04469530 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.