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NCT00073398 · ClinicalTrials.gov registry record · Phase 1
Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
A Phase 1 study of Squamous Cell Carcinoma and Lung Neoplasms, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT00073398 is a Phase 1 study of Squamous Cell Carcinoma and Lung Neoplasms that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 54 participants, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00073398, a Phase 1 study of Squamous Cell Carcinoma and Lung Neoplasms, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This 2-phase study will determine the safety of treating patients with non-small cell lung cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed lung cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink. Patients 18 years of age or older with non-small cell lung cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, urinalysis, chest x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be obtained if needed. Participants will receive four vaccinations a month apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the first year after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects: * Medical history and physical examination * Blood tests * X-rays and various scans (nuclear medicine/CT/MRI) * FACT-L Assessment questionnaire to measure the i
Conditions Studied
Interventions
- BIOLOGICAL Drug: Hyperacute Lung Cancer Cell Vaccine
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2003-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00073398
The ClinicalTrials.gov registry entry for NCT00073398 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (48% lower). The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Drug: Hyperacute Lung Cancer Cell Vaccine is the first listed.
NCT00073398 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00073398 about?
NCT00073398 is a clinical study titled "Vaccine Treatment for Advanced Non-Small Cell Lung Cancer". This 2-phase study will determine the safety of treating patients with non-small cell lung cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains kill...
What is the current status of trial NCT00073398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2003-11. Estimated completion is 2013-03.
What conditions does trial NCT00073398 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma, Lung Neoplasms, Non-small Cell Carcinoma, Adenocarcinoma of Lung, Large Cell Carcinoma.
What interventions are being tested in trial NCT00073398?
The interventions under investigation include: Drug: Hyperacute Lung Cancer Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00073398?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00073398 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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