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NCT00066365 · ClinicalTrials.gov registry record · Phase 2

Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

A Phase 2 study of Sarcoma and Metastatic Cancer, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
49
Enrollment target
20
Study locations

NCT00066365 is a Phase 2 study of Sarcoma and Metastatic Cancer that has completed, run by Children's Oncology Group. The registered enrollment target is 49 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00066365, a Phase 2 study of Sarcoma and Metastatic Cancer, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
49 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung. PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.

Interventions

  • PROCEDURE conventional surgery
  • BIOLOGICAL sargramostim

Study Locations (20)

California

  • Southern California Permanente Medical Group - Downey
  • Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital - Long Beach
  • Children's Hospital and Research Center Oakland - Oakland
  • University of California Davis Cancer Center - Sacramento
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
  • Stanford Cancer Center - Stanford

Florida

  • Lee Cancer Care of Lee Memorial Health System - Fort Myers
  • University of Florida Shands Cancer Center - Gainesville
  • Nemours Children's Clinic - Jacksonville
  • University of Miami Sylvester Comprehensive Cancer Center - Miami - Miami
  • Miami Children's Hospital - Miami
  • Baptist-South Miami Regional Cancer Program - Miami

Arizona

  • Phoenix Children's Hospital - Phoenix
  • Arizona Cancer Center at University of Arizona Health Sciences Center - Tucson

District of Columbia

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center - Washington D.C.
  • Children's National Medical Center - Washington D.C.

Alabama

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham - Birmingham

Arkansas

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences - Little Rock

Delaware

  • Alfred I. duPont Hospital for Children - Wilmington

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2004-07
Est. Completion 2013-12
Phase Phase 2

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT00066365

The ClinicalTrials.gov registry entry for NCT00066365 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (95% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which conventional surgery is the first listed.

NCT00066365 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00066365 about?

NCT00066365 is a clinical study titled "Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma". RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma th...

What is the current status of trial NCT00066365?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2004-07. Estimated completion is 2013-12.

What conditions does trial NCT00066365 study?

This clinical trial studies the following conditions: Sarcoma, Metastatic Cancer.

What interventions are being tested in trial NCT00066365?

The interventions under investigation include: conventional surgery (PROCEDURE), sargramostim (BIOLOGICAL).

Who is sponsoring clinical trial NCT00066365?

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

Where is trial NCT00066365 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Delaware. 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.