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.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00006470
First received: November 6, 2000
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: monoclonal antibody 11D10 anti-idiotype vaccine
Biological: monoclonal antibody 3H1 anti-idiotype vaccine
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: March 2001
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006470

  Show 237 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Benjamin Movsas, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00006470     History of Changes
Other Study ID Numbers: RTOG-9909, CDR0000068293
Study First Received: November 6, 2000
Last Updated: August 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014