SCCA Clinical Studies: Lung Cancer
Carcinoma, Non-Small-Cell Lung: Stage IIIA (T3,N2 Only)
Carcinoma, Non-Small-Cell Lung: Stage IIIB
Carcinoma, Non-Small-Cell Lung: Stage IV
Rationale: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than a placebo as maintenance therapy in treatment of subjects with non-small cell lung cancer.
Purpose: This randomized phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with stage III or stage IV non-small cell lung cancer.
|Ages Eligible for Study:||18 Years to 75 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Subjects with histologically or cytologically confirmed NSCLC who meet one of the following staging requirements:
- Stage IIIA (T3N2 only) or
- Stage IIIB or
- Stage IV.
- Subjects must have stable disease (SD) or an objective response (PR or CR) to a prior single, frontline, platinum-based chemotherapy regimen (additional prior adjuvant chemotherapy is permitted) consisting of up to six (6) treatment cycles with or without concomitant radiation therapy.
- Not less than one month nor more than four months must have elapsed since the completion of the last chemotherapy cycle and registration into the study.
- Signed informed consent.
- Not less than 18 years and not more than 75 years old.
- Estimated life expectancy of at least 12 weeks.
- Performance status (ECOG) ≤ 2.
- Absolute neutrophil count ≥ 1,500/mm3.
- Hemoglobin ≥ 9 g/dL.
- Platelet count ≥ 100,000/mm3.
- Albumin levels ≥ 3.5 g/dL.
- Bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 1.5 × ULN.
- Creatinine ≤ 1.5 × ULN.
- Alkaline phosphatase ≤ 5 × ULN.
- Concurrent systemic steroids > 2 mg /day prednisone (or prednisone-equivalent of prednisolone or dexamethasone).
- Prior splenectomy.
- Any surgery involving general anesthesia < 4 weeks prior to study registration.
- Chemotherapy more than 4 months or less than 4 weeks prior to study registration.
- Steroid therapy (excluding ≤ 2 mg/day prednisone or prednisone-equivalent of prednisolone or dexamethasone), radiation therapy, or immunotherapy less than 4 weeks prior to study registration.
- Objective evidence of brain metastases.
- Painful bone metastases, or bone metastases that require immediate therapy.
- Significant and/or symptomatic pleural effusions. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, pleural effusions that cannot be controlled by previous chemotherapy and/or drainage, or other procedures, prior to study entry.
- Known allergies to eggs or soy.
- Significant weight loss (≥ 10% body weight in preceding 6 weeks).
- Known HIV positivity (EBV origin of replication in the pCHEK/HBA2 vector used to modify the vaccine components can trans-activate HIV).
- Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) or other conditions that, in the opinion of the investigator, would compromise study objectives.
- NCI CTC Grade 3 or 4 peripheral neuropathy at study registration.
- Prior other malignancies (excluding non-melanoma carcinomas of the skin) unless in remission for ≥ 2 years.
- History of psychiatric disorder that would impede ability to give informed consent or adherence to study requirements.
- Pregnant or nursing women, or refusal to practice contraception if of reproductive potential.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Known active Epstein-Barr infection within ≤ 60 days of study registration.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.