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NCT00049218 · ClinicalTrials.gov registry record · Phase 1
Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 1 study of Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT00049218: Completed Phase 1 study of Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00049218 is a Phase 1 study of Lung Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 56 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00049218, a Phase 1 study of Lung Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.
Primary Outcome
To evaluate the toxicity of the Ad-p53 dendritic cell (DC) vaccine. While there is no expected toxicity from the Ad-p53 vaccine, there may be unforeseen adverse effects. Patients will be monitored for toxicity, particularly for evidence of autoimmunity. Complete blood counts (CBCs) to monitor for hematologic toxicity, serum creatinine to monitor for renal toxicity, liver function tests (LFTs) to monitor for hepatic toxicity, and a standard clinical toxicity will be performed every other week thr
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Etoposide
- BIOLOGICAL Autologous dendritic cell-adenovirus p53 vaccine
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2003-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT00049218 record still lists
NCT00049218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT00049218 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00049218 about?
NCT00049218 is a clinical study titled "Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells. PUR...
What is the current status of trial NCT00049218?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2003-04. Estimated completion is 2014-05.
What conditions does trial NCT00049218 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT00049218?
The interventions under investigation include: Carboplatin (DRUG), Etoposide (DRUG), Autologous dendritic cell-adenovirus p53 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00049218?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00049218 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lung Cancer
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 NCT00049218's enrollment target sits among peer trials
56 255th of 409 higher than 153 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer 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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