Lung Cancer Clinical Trial
Official title:
Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)
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.
OBJECTIVES:
- Determine the progression-free and overall survival of patients with selected stage
IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine.
- Determine the response rate (confirmed and unconfirmed and complete and partial) in
patients treated with this vaccine.
- Determine the frequency and severity of toxic effects of this vaccine in these
patients.
- Determine the functional status of patients treated with this vaccine.
- Correlate systemic biologic activity (i.e., antigen-specific antitumor and systemic
cytokine responses) with clinical outcome in patients treated with this vaccine.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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