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Sponsored by: |
AVAX Technologies |
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Information provided by: | AVAX Technologies |
ClinicalTrials.gov Identifier: | NCT00298298 |
To determine if a vaccine made from patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer - Completely Resectable |
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | L-Vax: A Feasibility Study Using a DNP-Modified Autologous Tumor Cell Vaccine as Therapy in Patients With Resectable Non-Small Cell Lung Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
5 million autologous, DNP-modified NSCLC cells
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Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
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2: Experimental
2.5 million autologous, DNP-modified NSCLC cells
|
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
|
3: Experimental
0.5 million autologous, DNP-modified NSCLC cells
|
Biological: L-Vax: Autologous, DNP-Modified NSCLC Vaccine
autologous, DNP-modified NSCLC cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Alkaline phosphatase > 2.5 x ULN
Topical steroid therapies [applied to the skin] are allowed, provided these are not applied to limbs injected with vaccine or skin test materials.
Inhaled aerosol steroids are allowed.)
United States, Arkansas | |
Highlands Oncology Group | Recruiting |
Fayetteville, Arkansas, United States, 72703 | |
Contact: Kim Davison, RN 479-587-1700 ext 143 kdavison@hogonc.com | |
Principal Investigator: Daniel S. Bradford, MD | |
United States, Pennsylvania | |
University of Pennsylvania Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jennifer Beecham, RN 215-662-9647 Jennifer.Beecham@uphs.upenn.edu | |
Contact: Joseph Friedberg, ND 215-662-9640 Joseph.Friedberg@uphs.upenn.edu | |
Principal Investigator: Joseph Friedberg, MD |
Study Director: | Francois Martelet, MD | AVAX Technologies |
Responsible Party: | AVAX Technologies ( Francois Martelet, MD - Chief Executive Officer ) |
Study ID Numbers: | A/100/0601 |
Study First Received: | February 28, 2006 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00298298 History of Changes |
Health Authority: | United States: Food and Drug Administration |
lung cancer non-small cell lung cancere vaccine immunotherapy |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
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 |