Full Text View
Tabular View
No Study Results Posted
Related Studies
Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
This study has been completed.
Study NCT00006470   Information provided by National Cancer Institute (NCI)
First Received: November 6, 2000   Last Updated: July 23, 2009   History of Changes

November 6, 2000
July 23, 2009
March 2001
December 2004   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00006470 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
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.

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.

Phase II
Interventional
Treatment
Lung Cancer
  • Biological: monoclonal antibody 11D10 anti-idiotype vaccine
  • Biological: monoclonal antibody 3H1 anti-idiotype vaccine
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
December 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006470
 
CDR0000068293, RTOG-9909
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Benjamin Movsas, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP