Phase II Trial of CG8123, an Autologous Cancer Vaccine (GVAX), in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma (BAC)

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.