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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 (NCT00003974)

RATIONALE: Vaccines made from a person's tumor may help the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have undergone surgery to remove stage I, stage II, or stage IIIA non-small cell lung cancer or stage I or stage II mesothelioma.
  • Biological: lung tumor associated antigen
    • Drug: DetoxPC
      • Drug: chemotherapy
        • Drug: cyclophosphamide
          Ages eligible for Study
          20 Years to 70 Years
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          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.

          1 locations

          United States (1)
          • Roswell Park Cancer Institute
            Not specified
            Buffalo, New York, United States, 14263-0001
          Status:
          completed
          Type:
          Interventional
          Phase:
          Start:
          31 July, 1997
          Updated:
          02 March, 2011
          Participants:
          20
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