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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074295 |
RATIONALE: Vaccines made from a person's tumor tissue may make the body build an immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with stage IIIB or stage IV bronchoalveolar (lung) cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Biological: GVAX lung cancer vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC) |
Study Start Date: | March 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma (BAC) (yes vs no) and pattern of BAC (diffuse vs nodular).
After successful vaccine manufacturing from tumor tissue procured, patients receive GVAX lung cancer vaccine intradermally (ID) (6-7 injections per vaccination) on weeks 1, 3, 5, 7, and 9 for a total of 5 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at weeks 9, 13, and 21.
Patients are followed at 4 weeks, every 8 weeks for 1 year, and then every 12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 117 patients (67 previously untreated and 50 previously treated) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis* of 1 of the following by radiological features and clinical presentation:
Bronchoalveolar carcinoma (BAC)
Tumor accessible for tissue procurement via thoracentesis or a surgical procedure
Resection of brain metastases may be used for vaccine processing
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Patients requiring surgery for tumor tissue procurement must meet the following criteria:
Pulmonary
Patients requiring thoracoscopic surgery or thoracotomy for tumor tissue procurement must meet the following criteria:
Immunologic
No hypersensitivity to any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
More than 4 weeks since prior chemotherapy
Endocrine therapy
Radiotherapy
More than 4 weeks since prior radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000343797, SWOG-S0310 |
Study First Received: | December 10, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00074295 History of Changes |
Health Authority: | United States: Federal Government |
bronchoalveolar cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Adenocarcinoma, Bronchiolo-Alveolar Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Adenocarcinoma Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Lung Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |