Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Vaccine Treatment; Cyclophosphamide; All-trans retinoic acid (ATRA)
Intervention description: We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.; Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.; All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Intervention MeSH terms: Cyclophosphamide; Tretinoin; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the lung; stage IV non-small cell lung cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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