Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Patient with Non Small Cell Lung Cancer (NSCLC) who has been treated with palliative radiotherapy and/or at least three courses of chemotherapy, and has achieved stable disease (SD), partial response (PR) or complete response (CR) confirmed by CT scan at least 4 weeks after end of treatment. Previous curative radiotherapy is allowed as long as the patient has relapsed and received palliative chemotherapy.
No evidence of disease progression at the time of inclusion
Must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Must be at least 18 years of age.
Must have lab values as follows:
White Blood Cells ≥ 1.5 x 109/L
Platelets ≥ 100 x 109/L
Hemoglobin ≥ 9g/dL (≥ 5.6 mmol/L)
Creatinine ≥ 140 µmol/L
Bilirubin < 20% above the upper limit of normal
ASAT and ALAT ≤ 2.5 the upper limit of normal
Albumin ≥ 2.5 g/L
Signed informed consent

Exclusion Criteria:

History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug.
Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome.
Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.

Known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may however participate provided they meet the following criteria:

Inactive metastases (without evidence of progression which is documented by CT or MRI within 4 weeks prior to the planned study treatment date), and
If prednisolone or equivalent treatment is required; no more </=10mg/day is permitted.
Active infection requiring antibiotic therapy.
Pregnancy or lactation.
Woman of childbearing potential not using any reliable and adequate contraceptive methods defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy.
Known hypersensitivity to any of the components of the vaccine
Known hypersensitivity to Leukine®, yeast derived products or any component of the product
Patients who test positive for hepatitis B, C or HIV.
Any other anti-tumor treatment within 4 weeks of study entry (including chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors and gene therapy).
Use of not permitted concomitant medication:
chronic corticosteroids except for asthma inhalers / topical use
any agent with a known effect on the immune system, unless it is being given at dose levels that are not immunosuppressive, e.g. prednisone at 10mg/day or less.
any alternative and complementary drugs that may affect the immune system or be potentially harmful to patients participating in phase I studies.
Any reason why, in the opinion of the investigator, the patient should not participate.