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

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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


- 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

- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- Not specified


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- No superior vena cava syndrome


- FEV_1 at least 1.0 L


- 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


- 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

- 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


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

- 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


- 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


- No prior thoracic radiotherapy


- See Disease Characteristics


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Benjamin Movsas, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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