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
lung tumor associated antigen
+ DetoxPC
+ chemotherapy
Adénome+14
+ Néoplasmes bronchiques
+ Carcinome bronchogénique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1997
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.20 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 20 à 70 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically proven primary stage I (T2, N0), II, or IIIA non-small cell lung cancer (NSCLC) curatively resected by pneumonectomy, lobectomy, or wedge resection OR Stage I or II mesothelioma Measurable disease Lesions must be at least 3 cm in diameter PATIENT CHARACTERISTICS: Age: 20 to 70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy except nonmelanoma skin cancer No history of severe allergies No history of autoimmune disease Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent glucocorticoids Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent nonsteroidal antiinflammatory drugs
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Roswell Park Cancer Institute
Buffalo, United StatesOuvrir Roswell Park Cancer Institute dans Google Maps