Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.

Key facts

Study ID

NCT00601796

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

24

Starts

2006-10-01

Expected to finish

2012-06-01

Last updated by the study team

2013-05-24

Who can join

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

You may qualify if…

• Histologically confirmed metastatic adenocarcinoma of the lung
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
• No radiation therapy within 2 weeks of first vaccine administration
• No chemotherapy within 4 weeks of first vaccine administration
• No steroid therapy within 4 weeks of first vaccine administration
• Patient's written informed consent
• Adequate organ function (measured within a week of beginning treatment)
• Patients will be tested for human leukocyte antigen A0201 (HLA-A0201) as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen, however this result will not be an inclusion criterion.
• Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter greater than or equal 20mm. With spiral computer tomography (CT) scan, lesion must be greater than or equal to 10 mm at least one dimension.
• Patient's must have received, and completed first line chemotherapy.

You may not qualify if…

• Symptomatic brain metastasis
• Any acute medical problems requiring active intervention
• Current corticosteroid (other than replacement doses in patients who are hypoadrenal) or other immunosuppressive therapy
• Any other pre-existing immunodeficiency condition (including known HIV infection)
• Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).
• Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3 or 4

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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