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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: Completed Phase 2 study of Sarcoma and Metastatic Cancer, sponsored by Children's Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2004-07 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00066365 record still lists
NCT00066365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (95% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
Similar trials for 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 NCT00066365's enrollment target sits among peer trials
49 69th of 122 higher than 54 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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