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NCT00828009 · ClinicalTrials.gov registry record · Phase 2
BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase 2 study of Lung Cancer, sponsored by ECOG-ACRIN Cancer Research Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT00828009: Completed Phase 2 study of Lung Cancer, sponsored by ECOG-ACRIN Cancer Research Group.
NCT00828009 is a Phase 2 study of Lung Cancer that has completed, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 70 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00828009, a Phase 2 study of Lung Cancer, has completed, sponsored by ECOG-ACRIN Cancer Research Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine therapy together with bevacizumab after chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine together with bevacizumab after chemotherapy and radiation therapy in treating patients with newly diagnosed stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery.
Primary Outcome
The study is to evaluate the safety of the combination of tecemotide immunotherapy with bevacizumab. The target adverse events for the combined treatment are as follows: grade 4-5 hemorrhage, esophagitis, fistula, platelet count decrease (thrombocytopenia), encephalitis infection, or hepatic failure episodes.
Conditions Studied
Interventions
- DRUG carboplatin
- DRUG cyclophosphamide
- DRUG paclitaxel
- BIOLOGICAL bevacizumab
- BIOLOGICAL Tecemotide
Study Locations (20)
Illinois
- St. Joseph Medical Center - Bloomington
- Graham Hospital - Canton
- Memorial Hospital - Carthage
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
- Hematology and Oncology Associates - Chicago
- Saint Joseph Hospital - Chicago
- Decatur Memorial Hospital Cancer Care Institute - Decatur
- Eureka Community Hospital - Eureka
- Galesburg Clinic, PC - Galesburg
- Ingalls Cancer Care Center at Ingalls Memorial Hospital - Harvey
- Mason District Hospital - Havana
- Kellogg Cancer Care Center - Highland Park
- Hinsdale Hematology Oncology Associates - Hinsdale
- Provena St. Mary's Regional Cancer Center - Kankakee - Kankakee
- North Shore Oncology and Hematology Associates, Limited - Libertyville - Libertyville
- McDonough District Hospital - Macomb
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus - Moline
California
- Veterans Affairs Medical Center - Palo Alto - Palo Alto
- Stanford Cancer Center - Stanford
Georgia
- Medical Center of Central Georgia - Macon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-01-17 |
| Est. Completion | 2019-05-22 |
| Phase | Phase 2 |
What the finished NCT00828009 record still lists
NCT00828009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which carboplatin is the first listed.
NCT00828009 names 20 study sites across 3 states, led by Illinois, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00828009 about?
NCT00828009 is a clinical study titled "BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery". RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-kill...
What is the current status of trial NCT00828009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-01-17. Estimated completion is 2019-05-22.
What conditions does trial NCT00828009 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT00828009?
The interventions under investigation include: carboplatin (DRUG), cyclophosphamide (DRUG), paclitaxel (DRUG), bevacizumab (BIOLOGICAL), Tecemotide (BIOLOGICAL).
Who is sponsoring clinical trial NCT00828009?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00828009 being conducted?
This trial has 20 study locations across California, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00828009's enrollment target sits among peer trials
70 224th of 409 higher than 182 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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