Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
NCT00066365 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00066365
The ClinicalTrials.gov registry entry for NCT00066365 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00066365 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00066365?
The interventions under investigation include: conventional surgery (PROCEDURE), sargramostim (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00066365?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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