Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage IIIA Non-small Cell Lung Cancer or With Stage I or Stage II Mesothelioma
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.
|Lung Cancer Malignant Mesothelioma||Biological: lung tumor associated antigen Drug: DetoxPC Drug: chemotherapy Drug: cyclophosphamide||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||August 1997|
|Study Completion Date:||November 2000|
|Primary Completion Date:||June 1998 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003974
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Timothy M. Anderson, MD||Roswell Park Cancer Institute|