Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Lung Cancer

In brief

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IIIB or stage IV non-small cell lung cancer who have finished first-line chemotherapy.

Key facts

Study ID

NCT00534209

Run by

University of Miami

People needed

1

Starts

2009-01-01

Expected to finish

2010-04-01

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with stage IIIB (non-candidates for radiation) or stage IV pathologically confirmed non-small cell carcinoma of the lung that completed 4-6 cycles of platinum based first line chemotherapy and achieved complete response (CR), partial response (PR) or stable disease.
• Last administration of chemotherapy occurred no later than 4 weeks prior to the enrollment date.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Renal Requirements: The calculated creatinine clearance must be at least 50 ml/min.
• Pulmonary Function Requirements:
• All patients will undergo evaluation of pulmonary function prior to enrollment.
• Patients should have a Forced expiratory volume in 1 second (FEV1) more than 30% of the predicted value and/or Diffusing capacity (DLCO) more than 30% of the predicted value with a partial pressure of carbon dioxide (PCO2) < 45mm.
• Any patient enrolled in the protocol whose respiratory symptoms have experienced marked deterioration not related to a known cause (e.g. pneumonia, congestive heart failure (CHF) or pulmonary embolism (PE)) will have request pulmonary function test (PFT) evaluation and if the above parameters are seen will be excluded from the protocol.
• Age ≥ 18 years.
• Signed informed consent.
• Patients should have absolute neutrophil count (ANC) ≥ 1000/mm3; platelets (PLT) ≥ 80,000/mm3.

You may not qualify if…

• Small cell carcinoma of the lung.
• Existing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease etc; colitis, inflammatory bowel disease or pancreatitis within 10 years of study.
• Other active malignancies present within the past three years, except for basal and/or squamous cell carcinoma(s) or in situ cervical cancer.
• Concomitant steroid or other immunosuppressive therapy.
• Active infection, or less than 7 days since therapy for acute infections.
• Pericardial effusion.
• Currently receiving chemotherapy for another condition (such as arthritis).
• Time elapsed greater than 4 weeks since last administration of first line chemotherapy for NSCLC.
• Active or symptomatic cardiac disease such as congestive heart failure, angina pectoris or recent myocardial infarction.
• Pregnant or lactating women (negative test for pregnancy required of women of childbearing potential).
• Refusal in fertile men or women to use effective birth control measures during and for six months after the completion of treatment on study.
• Known HIV infection
• Untreated or uncontrolled brain metastasis.
• Liver Enzymes greater than 3 times the institutional upper limit.

Where it is running

• Memorial Regional Hospital — Hollywood, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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