Lung Cancer
Conditions
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery.
Detailed description
OBJECTIVES: * Determine the humoral and T-cell response to adjuvant monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine with radiotherapy in patients with completely resected stage II or IIIA non-small cell lung cancer. * Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. * Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning 2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2 years regardless of disease progression. Beginning no more than 1 week after the third postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks. Patients with extracapsular nodal metastases or T3 lesions also undergo 6 additional radiotherapy boosts. Patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage II or IIIA non-small cell lung cancer * T1-3, N1-2, M0 * No stage IIIB (e.g., contralateral N3), stage IV (M1), or T3, N0, M0 disease * N1 disease eligible only if hilar lymph node involvement present * No bronchoalveolar carcinoma with lobar or multilobar involvement * No small cell lung carcinoma, including mixed histology * No more than 7 weeks since prior surgery (lobectomy, sleeve resection, bilobectomy, or pneumonectomy) * Negative surgical margins * No incompletely resected gross disease OR * No microscopically positive bronchial or vascular margins * No known CNS metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No superior vena cava syndrome Pulmonary: * FEV\_1 at least 1.0 L Gastrointestinal: * No prior celiac disease, familial polyposis, Turcot's syndrome, Gardner's syndrome, Peutz-Jegher's syndrome, or hereditary non-polyposis colon cancer * No prior colitis, inflammatory bowel disease, or pancreatitis within the past 10 years Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No known sensitivity to rodent proteins * No prior hypersensitivity or contraindication to study treatments (e.g., monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody 3H1 anti-idiotype vaccine, aluminum hydroxide, or murine proteins) or any excipients * No prior clinically significant hypersensitivity reactions (e.g., angioedema, anaphylaxis, or serious dermatological manifestations) or asthmatic attacks requiring hospitalization * No prior immune or immunodeficiency disorders (e.g., HIV, sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders) * No prior seizure disorder requiring continuous medication * No active infection * No other prior or concurrent malignancy within the past 3 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer * No medical contraindication to surgery, radiotherapy, or immunotherapy * No prior drug or alcohol abuse (excluding nicotine) within the past 12 months * No prior psychiatric or addictive disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine antibodies (e.g., OncoScint scan) * No prior monoclonal antibody 11D10 anti-idiotype vaccine, monoclonal antibody 3H1 anti-idiotype vaccine, or other investigational carcinoembryonic antigen-derived therapy * At least 3 years since other prior immunotherapy * At least 30 days since prior immunization (e.g., influenza) * No immunomodulatory therapy (e.g., gold, auranofin, hydroxychloroquine, sulfasalazine, penicillamine, levamisole, dapsone, azathioprine, intravenous immunoglobulin, leukotriene antagonists, cromoglycate, ketotifen, nedocromil, psoralin-ultraviolet-light, or plasmapheresis) within 30 prior to the first dose of study drug or 5 half-lives of the action of the agent, whichever is longer Chemotherapy: * At least 3 years since prior chemotherapy except topical therapy * No concurrent methotrexate or cyclophosphamide Endocrine therapy: * At least 45 days since prior corticosteroids * No concurrent systemic corticosteroids Radiotherapy: * No prior thoracic radiotherapy Surgery: * See Disease Characteristics Other: * At least 45 days since prior immunosuppressants * No investigational agents within 30 prior to the first dose of study drug or 5 half-lives of the action of the agent, whichever is longer * No concurrent amifostine * No concurrent cyclosporine * No other concurrent immunosuppressants * No concurrent chronic systemic antihistamines
Countries
Canada, United States