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.
Full Title of Study: “Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer”
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
- Study Primary Completion Date: December 2004
- 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.
- Biological: monoclonal antibody 11D10 anti-idiotype vaccine
- Biological: monoclonal antibody 3H1 anti-idiotype vaccine
- Radiation: radiation therapy
Participating in This Clinical Trial
- 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
- 18 and over
- Zubrod 0-1
- Not specified
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Not specified
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No superior vena cava syndrome
- FEV_1 at least 1.0 L
- 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
- 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:
- 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
- At least 3 years since prior chemotherapy except topical therapy
- No concurrent methotrexate or cyclophosphamide
- At least 45 days since prior corticosteroids
- No concurrent systemic corticosteroids
- No prior thoracic radiotherapy
- See Disease Characteristics
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Radiation Therapy Oncology Group
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Overall Official(s)
- Benjamin Movsas, MD, Study Chair, Fox Chase Cancer Center
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