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| Sponsored by: |
Corixa Corporation |
|---|---|
| Information provided by: | Corixa Corporation |
| ClinicalTrials.gov Identifier: | NCT00062907 |
Purpose
The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Biological: Recombinant DNA- pVAX/L523S Biological: Recombinant adenovirus- Ad/L523S |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 9 |
| Study Start Date: | May 2003 |
The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two doses of pVAX/L523S and two doses of Ad/L523S.
The secondary objectives of the study are:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations| United States, Florida | |
| Cancer Centers of Florida | Recruiting |
| Ocoee, Florida, United States, 34761 | |
| Contact: Bobbi Rehm, RN 407-292-3042 brehm@usoncology.com | |
| Principal Investigator: Barry S. Berman, MD | |
| United States, Texas | |
| Mary Crowley Medical Research Clinic | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Jennifer Edwards 214-658-1944 jedwards@mcmrc.com | |
| Principal Investigator: John Nemunaitis, MD | |
| Tyler Cancer Center | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Linda Dunklin, RN 903-579-9800 linda.dunklin@usoncology.com | |
| Principal Investigator: Donald Richards, MD | |
| United States, Washington | |
| Cancer Care Northwest | Recruiting |
| Spokane, Washington, United States, 99218 | |
| Contact: Rose Miller, RN, OCN 509-228-1432 rosalee.miller@usoncology.com | |
| Principal Investigator: Stephen Anthony, D.O. | |
| Swedish Cancer Institute | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Jane Arthur, RN 206-386-6921 jane.arthur@swedish.org | |
| Principal Investigator: Howard West, MD | |
More Information
| Study ID Numbers: | CCL5001-01 |
| Study First Received: | June 17, 2003 |
| Last Updated: | December 5, 2006 |
| ClinicalTrials.gov Identifier: | NCT00062907 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adenoviridae Infections |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |