Trial Information

An Evaluation of the Immunological Parameters Associated With a Skin-Test and Immunization of Lung and Mesothelioma Cancer Patients With Autologous Lung Tumor Associated Antigen: Characterization of the Patients' Cytolytic and Helper T Cell Reactivity for Identification of the Specific Antigen(s): A Pilot Study

OBJECTIVES: I. Define the immunological parameters of cytolytic T cell and T helper cell
activity associated with skin testing and vaccination with autologous lung tumor associated
antigen and detoxPC in patients with curatively resected stage I, II, or IIIA non-small cell
lung cancer (NSCLC) or stage I or II mesothelioma. II. Evaluate any responses associated
with an enhanced antitumor immune status in this patient population with this treatment
regimen.

OUTLINE: Patients undergo delayed type hypersensitivity skin testing with autologous tumor
associated antigen (TAA) and memory antigens (i.e., Monilia, PPD, and Trichophyton)
intradermally at 1-4 weeks following surgical tumor resection. At week 4-9, patients receive
low dose cyclophosphamide IV once. At 3 days following chemotherapy, patients receive
autologous TAA with DetoxPC intradermally for up to 3 doses over 4 weeks. At 2-3 weeks
following vaccination, patients undergo repeat skin testing. At week 6-12, patients with a
positive skin test undergo biopsy of the skin test/vaccination site followed by
leukapheresis at week 12-20 if T cells exhibit active antitumor reactivity. Patients with
stable or regressive disease receive additional vaccination courses at week 20 and
thereafter. Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.