NCT00006470
Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
PHASE2
COMPLETED
NCT00006470
INTERVENTIONAL
Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients With Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer
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.
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
Lung Cancer
- TREATMENT
-
- Type: BIOLOGICAL
- Name: monoclonal antibody 11D10 anti-idiotype vaccine
- Description:
- Arm Group Labels:
-
- Type: BIOLOGICAL
- Name: monoclonal antibody 3H1 anti-idiotype vaccine
- Description:
- Arm Group Labels:
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:
- Radiation Therapy Oncology Group