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
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|ClinicalTrials.gov Identifier: NCT00003974|
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Malignant Mesothelioma||Biological: lung tumor associated antigen Drug: DetoxPC Drug: chemotherapy Drug: cyclophosphamide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
|Actual Primary Completion Date :||June 1998|
|Actual Study Completion Date :||November 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|