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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
  • Study Primary Completion Date: December 2004

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.

Interventions

  • Biological: monoclonal antibody 11D10 anti-idiotype vaccine
  • Biological: monoclonal antibody 3H1 anti-idiotype vaccine
  • Radiation: radiation therapy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radiation Therapy Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin Movsas, MD, Study Chair, Fox Chase Cancer Center

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