To Immunize Patients With Extensive Stage SCLC Combined With Chemo With or Without All Trans Retinoic Acid

Exclusion Criteria

• •Patients with severe, uncontrolled intercurrent illness or infection
• •Anticipated requirement for systemic chronic steroid use at the time of vaccination, unless specifically indicated for dose supplementation or replacement of established corticosteroid insufficiency
• •Receiving systemic doses of corticosteroids should have them discontinued ≥ 2 weeks prior to starting vaccination (this include patients receiving steroids with PCI). Inhaled steroids should also be discontinued if at all possible. Chronic, stable doses of inhaled steroids for the treatment of chronic obstructive pulmonary disease (COPD), etc. are allowed if in the opinion of the treating physician(s) they cannot be stopped.
• •Any pre-existing immunodeficiency condition, or a known history of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
• •Uncontrolled and/or symptomatic central nervous system (CNS) metastasis
• •Pregnant or lactating women. A pregnancy test-serum Beta human chorionic gonadotropin (bHCG) will be obtained during the screening process.
• •Have received any chemotherapy other than the first line chemotherapy specified in the study protocol: standard platinum/etoposide regimen
• •Have received any prior investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy for treatment of SCLC
• •Any known pre-existing autoimmune disorder
• •History of a second malignancy within the previous 3 years. Exceptions include: non-melanoma skin cancers, any in-situ carcinomas and successfully treated early stage malignancies without evidence of recurrence for \> 18 months.
• •Have not recovered from any chemotherapy-related or other therapy-related toxicity at study entry
• •Have had major surgery without full recovery or major surgery within 3 weeks of the start of vaccine treatment
• •Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study
• •Pre-Pheresis Criteria:
• •Patients must have had a successful harvest of peripheral blood mononuclear cell (PBMC) with leukopheresis at least 6-10 weeks after chemotherapy.
• •ECOG performance status of 0-2
• •The last dose of first line chemotherapy must have been administered at least 4 weeks prior to the first vaccine administration.
• •Patients who received radiation therapy: last dose of radiation must have been completed at least 2 weeks prior to the first vaccine administration and the patient must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia)
• •Patients who received steroid therapy: last steroid dose must have been given at least 2 weeks prior to the first vaccine administration
• •Adequate organ function:
• •* WBC \> 2,500/mm³ and ANC \>1,200/mm³
• •* Platelets \> 75,000/mm³
• •* Hematocrit \> 25%
• •* Hemoglobin ≥9g/dl
• •* Bilirubin \< 2.0 mg/dl
• •* Creatinine \< 2.0 mg/dL
• •* AST/SGOT ≤ 2 x ULN
• •* Alkaline phosphatase \< 3 x ULN
• •Patients must have signed informed consent at initial registration.
• •HLA-A\*0201 Testing as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen, however this result will not be an inclusion criterion
• •Pre-Paclitaxel Eligibility:
• •Progressive disease after observation (Arm A) or vaccinations (Arms B and C)
• •ECOG performance status of 0-2
• •Adequate organ function:
• •* WBC \> 2,500/mm³ and ANC \>1,200/mm³
• •* Platelets \> 75,000/mm³
• •* Hematocrit \> 25%
• •* Hemoglobin ≥9g/dl
• •* Bilirubin \< 2.0 mg/dl
• •* Creatinine \< 2.0 mg/dL
• •* AST/SGOT ≤ 2 x ULN
• •* Alkaline phosphatase \< 3 x ULN