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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Lung Cancer Malignant Mesothelioma |
Biological: lung tumor associated antigen Drug: DetoxPC Drug: chemotherapy Drug: cyclophosphamide |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 20 |
Study Start Date: | August 1997 |
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.
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
Study ID Numbers: | CDR0000067177, RPCI-DS-96-25, NCI-G99-1551 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003974 History of Changes |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II non-small cell lung cancer localized malignant mesothelioma stage IIIA non-small cell lung cancer |
Thoracic Neoplasms Immunologic Factors Cyclophosphamide Immunosuppressive Agents Carcinoma Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Mesothelioma Non-small Cell Lung Cancer Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Carcinoma, Non-Small-Cell Lung Adenoma Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Alkylating Agents Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Myeloablative Agonists Mesothelioma Antineoplastic Agents, Alkylating Antirheumatic Agents Adenoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |