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NCT04388839 · ClinicalTrials.gov registry record · Phase 2

Evolutionary Therapy for Rhabdomyosarcoma

A Phase 2 study of Rhabdomyosarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Active
Registry status
Phase 2
Development phase
12
Enrollment target
18
Study locations

NCT04388839 is a Phase 2 study of Rhabdomyosarcoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 12 participants, below the 69-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (83% lower). The trial reports 18 study locations across 10 states.

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The verdict

NCT04388839, a Phase 2 study of Rhabdomyosarcoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
12 participants
Enrollment target
18
Study locations

Study Summary

This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Vincristine
  • DRUG Vinorelbine
  • DRUG Actinomycin D
  • DRUG Cyclophosphamide Pill

Study Locations (18)

Florida

  • University of Florida - Gainesville
  • University of Miami - Sylvester Comprehensive Cancer Center - Miami
  • Johns Hopkins All Children's Hospital - St. Petersburg
  • Moffitt Cancer Center - Tampa

North Carolina

  • University of North Carolina Lineberger Comprehensive Cancer Center - Chapel Hill
  • Carolinas Medical Center, Levine Cancer Institute - Charlotte
  • Duke Children's Hospital - Durham

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo
  • Montefiore Medical Cancer Center - The Bronx

Ohio

  • Cleveland Clinic - Cleveland
  • Nationwide Children's Hospital - Columbus

Texas

  • University of Texas Southwestern Medical Center - Dallas
  • MD Anderson - Houston

Alabama

  • University of Alabama at Birmingham Comprehensive Cancer Center - Birmingham

Colorado

  • Children's Hospital of Colorado - Aurora

Connecticut

  • Connecticut Children's Medical Center - Hartford

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-12-29
Est. Completion 2027-08
Phase Phase 2

What the Registry Record Tells You About NCT04388839

The ClinicalTrials.gov registry entry for NCT04388839 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 69-participant average among 35 other Rhabdomyosarcoma trials with a reported enrollment target (83% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rhabdomyosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT04388839 reports 18 study locations spanning 10 distinct geographic areas - top geographies include Florida, North Carolina, New York.

Frequently Asked Questions

What is clinical trial NCT04388839 about?

NCT04388839 is a clinical study titled "Evolutionary Therapy for Rhabdomyosarcoma". This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (ma...

What is the current status of trial NCT04388839?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2020-12-29. Estimated completion is 2027-08.

What conditions does trial NCT04388839 study?

This clinical trial studies the following conditions: Rhabdomyosarcoma.

What interventions are being tested in trial NCT04388839?

The interventions under investigation include: Cyclophosphamide (DRUG), Vincristine (DRUG), Vinorelbine (DRUG), Actinomycin D (DRUG), Cyclophosphamide Pill (DRUG).

Who is sponsoring clinical trial NCT04388839?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04388839 being conducted?

This trial has 18 study locations across Alabama, Colorado, Connecticut, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.