NCT00006470

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

Official Title:

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

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.

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

Disease(s) and\or Condition(s)

Lung Cancer

Primary Purpose
  • TREATMENT
Intervention/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:
Sponsor
  • Radiation Therapy Oncology Group