Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: monoclonal antibody 11D10 anti-idiotype vaccine
* Biological: monoclonal antibody 3H1 anti-idiotype vaccine
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: monoclonal antibody 11D10 anti-idiotype vaccine|nan|
|Biological: monoclonal antibody 3H1 anti-idiotype vaccine|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer