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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019929 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: mutant p53 peptide pulsed dendritic cell vaccine Procedure: adjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy |
| Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks. Patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations.
Patients are followed for 5 years.
PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations:
Must have completed or plan to undergo curative intent therapy for NSCLC
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
No signs of acute hepatitis B infection
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Study Chair: | Jay A. Berzofsky, MD, PhD | NCI - Vaccine Branch |
More Information
| Study ID Numbers: | CDR0000067284, NCI-99-C-0142, VU-VCC-THO-9814, NCI-T96-0045 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00019929 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |