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NCT00070109 · ClinicalTrials.gov registry record · Phase 2

Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors

A Phase 2 study of Recurrent Ewing Sarcoma and Recurrent Childhood Rhabdomyosarcoma, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target
14
Study locations

NCT00070109: Completed Phase 2 study of Recurrent Ewing Sarcoma and Recurrent Childhood Rhabdomyosarcoma, sponsored by Children's Oncology Group.

NCT00070109 is a Phase 2 study of Recurrent Ewing Sarcoma and Recurrent Childhood Rhabdomyosarcoma that has completed, run by Children's Oncology Group. The registered enrollment target is 50 participants, below the 188-participant average among 9 other Recurrent Ewing Sarcoma trials with a reported enrollment target (73% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00070109, a Phase 2 study of Recurrent Ewing Sarcoma and Recurrent Childhood Rhabdomyosarcoma, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target
14
Study locations

Study Summary

This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.

Primary Outcome

Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with s

Interventions

  • OTHER pharmacological study
  • DRUG trabectedin

Study Locations (14)

New York

  • Roswell Park Cancer Institute - Buffalo
  • New York University Langone Medical Center - New York
  • Columbia University Medical Center - New York

Ontario

  • Chedoke-McMaster Hospitals - Hamilton
  • Hospital for Sick Children - Toronto

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

California

  • Children's Hospital Central California - Madera

Illinois

  • Childrens Memorial Hospital - Chicago

North Carolina

  • Wake Forest University Health Sciences - Winston-Salem

Ohio

  • Nationwide Children's Hospital - Columbus

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2008-01
Est. Completion 2013-12
Phase Phase 2
Children's Oncology Group

342 total trials

What the finished NCT00070109 record still lists

NCT00070109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 188-participant average among 9 other Recurrent Ewing Sarcoma trials with a reported enrollment target (73% lower).

The record links to 5 conditions, with Recurrent Ewing Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which pharmacological study is the first listed.

NCT00070109 lists 14 locations in 11 states (New York, Ontario, Arkansas).

Frequently Asked Questions

What is clinical trial NCT00070109 about?

NCT00070109 is a clinical study titled "Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors". This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.

What is the current status of trial NCT00070109?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-01. Estimated completion is 2013-12.

What conditions does trial NCT00070109 study?

This clinical trial studies the following conditions: Recurrent Ewing Sarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Previously Treated Childhood Rhabdomyosarcoma, Peripheral Primitive Neuroectodermal Tumor.

What interventions are being tested in trial NCT00070109?

The interventions under investigation include: pharmacological study (OTHER), trabectedin (DRUG).

Who is sponsoring clinical trial NCT00070109?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00070109 being conducted?

This trial has 14 study locations across Arkansas, California, Illinois, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent Ewing Sarcoma

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 NCT00070109's enrollment target sits among peer trials

50 4th of 9 higher than 6 of 9 other Recurrent Ewing Sarcoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Ewing Sarcoma 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 NCT00070109, the US trial registry maintained by the National Library of Medicine. NCT00070109 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.