Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT00420732
Eligibility Criteria:
Inclusion Criteria:
* histological diagnosis of non-small cell lung cancer. Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed NSCLC/small cell, and variant large and small are not eligible.
* AJCC Stage IIIB(pleural effusion) or Stage IV NSCLC
* Subjects must have been previously treated with only a first line platinum-doublet therapy that may or may not include Avastin(R). Those treated with definitive chemo-radiation with curative or palliative intent or who have received multiple regimens are not eligible.
* Subjects' NSCLC must have responded or remained stable through first line platinum-doublet therapy.
* ECOG Performance Status ≤ 2.
* Serum albumin ≥ 3.0 gm/dL.
* Expected survival ≥ 6 months.
* Hemoglobin ≥ 9.0 g/dl
* Platelets ≥ 100,000 cells/mm3
* ANC ≥ 1500 cells/mm3
* Serum total bilirubin ≤ 2 x ULN, ALT and AST ≤ 2.5 x ULN (≤5 if hepatic metastasis is present).
* Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 ml/min.
* Measurable or non-measurable disease.
* Subjects must have negative serology for HIV prior to entering study.
* Male and female subjects of child bearing potential must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving experimental drug, and for one month after the last immunization.
Exclusion Criteria:
* Age \< 18 years.
* Active CNS metastases or carcinomatous meningitis.
* Subjects' whose NSCLC progressed during/after first line platinum-doublet therapy.
* Subjects having undergone splenectomy.
* Hypercalcemia \> 2.9 mmol/L, unresponsive to standard therapy.
* Pregnant or nursing women.
* Other malignancy within the last 5 years, unless the probability of recurrence of the prior malignancy is \< 30%. Patient's curatively treated for squamous and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or subjects with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
* History of organ transplant.
* Current, active treatment with immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
* Subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible.
* Significant or uncontrolled congestive heart failure, myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
* Active infection or antibiotics within 1-week prior to study, including unexplained fever.
* Autoimmune disease.
* Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study.
* A known allergy to any component of the vaccine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00420732
Study Brief:
Protocol Section:
NCT00420732