Patient case: 11-year-old male with Peutz-Jeghers syndrome; genetic feature: STK11

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

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.

Eligibility: 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

Relevance to patient case: not relevant