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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-99-C-0142 | |||
| VU-VCC-THO-9814 | |||
| NCI-T96-0045 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mutant p53 peptide pulsed dendritic cell vaccine | Biological | |||
| adjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival by CTEP CTC v2.x | ||
| Overall survival by CTEP CTC v2.x | ||
| Toxicity by CTEP CTC v2.x |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological response by ELISPOT before and 2 weeks after last vaccine |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations:
No significant pleural effusions visible on plain chest radiography
Must have completed or plan to undergo curative intent therapy for NSCLC
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Bilirubin less than 2.0 mg/dL
SGOT less than 3 times normal
Albumin at least 3.0 g/dL
No signs of acute hepatitis B infection
No prior hepatitis C infection
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Jay A. Berzofsky, MD, PhD | NCI - Vaccine Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Read EJ, Carter CS, Lee J, et al.: Clinical scale preparation of antigen-pulsed mature autologous dendritic cells for tumor-specific immunotherapy. [Abstract] ISHAGE 2001 Seventh Annual Symposium A-100, 2001. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Vanderbilt-Ingram Cancer Center |
| Nashville |
| Tennessee |
| 37232-6838 |
| United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |