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NCT00514215 · ClinicalTrials.gov registry record · Phase 2
Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00514215: Completed Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT00514215 is a Phase 2 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00514215, a Phase 2 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cryotherapy together with GM-CSF works in treating patients with lung metastases or primary lung cancer.
Primary Outcome
CT-guided biopsy \& Peritumoral GM-CSF. a CR was defined as involution of the prior tumor and/or ablation site to only a thin, non-enhancing scar within the pulmonary parenchyma on enhanced chest CT. A PR was defined as incomplete resolution of an otherwise thoroughly hypovascular resolving ablation zone which had reached a diameter smaller than the original tumor size. Stable disease (SD) reflects no significant change in size of ablation site and/or overall tumor burden, while the standard def
Interventions
- PROCEDURE biopsy
- OTHER flow cytometry
- BIOLOGICAL sargramostim
- OTHER immunoenzyme technique
- PROCEDURE cryosurgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2006-01 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00514215 record still lists
NCT00514215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which biopsy is the first listed.
NCT00514215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00514215 about?
NCT00514215 is a clinical study titled "Cryotherapy and GM-CSF in Treating Patients With Lung Metastases or Primary Lung Cancer". RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving an injection of GM-CSF before cryotherapy and inhaling GM-CSF after cryotherapy may interfere with the growth of tumor cells and shrink the tumor. Giving cryotherapy together with GM-CSF may kill more tumor cells. PURPOSE: This phase...
What is the current status of trial NCT00514215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2006-01. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00514215?
The interventions under investigation include: biopsy (PROCEDURE), flow cytometry (OTHER), sargramostim (BIOLOGICAL), immunoenzyme technique (OTHER), cryosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT00514215?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00514215's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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