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NCT00617409 · ClinicalTrials.gov registry record · Phase 2
To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid
A Phase 2 study of Small-cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT00617409: Completed Phase 2 study of Small-cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00617409 is a Phase 2 study of Small-cell Lung Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 69 participants, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617409, a Phase 2 study of Small-cell Lung Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking and/or the amount of time that people who have this disease will live.
Primary Outcome
Overall Response: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). Efficacy of second line chemotherapy (single agent paclitaxel) after progression following the dendritic cell(DC)-based p53 vaccine (Ad.p53-DC vaccine), with (Arm C). To estimate the objective tumor response rate for each treatment group. Tumor response to be assessed via radiographic imaging after every 2 cycles of chemotherapy (paclitaxel). CR: Disappearance of all target lesions. PR: At least a 30% decreas
Conditions Studied
Interventions
- DRUG Paclitaxel
- BIOLOGICAL Drug: Ad.p53-DC vaccines
- DRUG All -trans Retinoic Acid (ATRA)
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2007-10-02 |
| Est. Completion | 2019-01-31 |
| Phase | Phase 2 |
What the finished NCT00617409 record still lists
NCT00617409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 231-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT00617409 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00617409 about?
NCT00617409 is a clinical study titled "To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid". The purpose of this research study is to test a tumor (cancer) vaccine given along with chemotherapy to determine if this vaccine will increase the chances of the tumor shrinking and/or the amount of time that people who have this disease will live.
What is the current status of trial NCT00617409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2007-10-02. Estimated completion is 2019-01-31.
What conditions does trial NCT00617409 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT00617409?
The interventions under investigation include: Paclitaxel (DRUG), Drug: Ad.p53-DC vaccines (BIOLOGICAL), All -trans Retinoic Acid (ATRA) (DRUG).
Who is sponsoring clinical trial NCT00617409?
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 NCT00617409 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
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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 NCT00617409's enrollment target sits among peer trials
69 45th of 79 higher than 35 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small-cell 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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