In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic
peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as
immunological response will be assessed. The purpose of this study is to select a biological
dose of peptides for further clinical trials.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
- No sign of brain metastases (excluded by MRI of brain).
- 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.
- 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.