A Vaccine Study for High Risk Cancers

Inclusion Criteria for Screening Phase:

Patient 1 to 70 years of age with neuroblastoma, rhabdomyosarcoma, or osteogenic sarcoma, who have one or more of the following high risk features:

* Neuroblastoma:

  * Stage IV disease
  * Stage III disease with n-myc amplification
* Osteogenic sarcoma:

  * Presence of metastases
  * Elevated alkaline phosphatase or LDH at diagnosis
  * Primary tumor affecting the axial skeleton
  * Poor histopathological response after completion of pre-surgical chemotherapy (≥10% viable tumor)
* Rhabdomyosarcoma:

  * Stage IV disease
  * Alveolar histology
  * Positive tumor margins, with lymph node positivity

Inclusion Criteria for Vaccine Phase:

* Patient meets all screening criteria and tumor is positive for NY-ESO-1, MAGE- A1, or MAGE-A3 by immunohistochemistry or RT-PCR.
* Patients who are between 3 months and 2 years following the completion of therapy, and have achieved at least a very good partial response to primary therapy.
* No chemotherapy is planned for one month following the last vaccination.
* Bilirubin \<2 mg/dL, and SGOT/SGPT \<2.5 x normal
* Creatinine clearance \> 50ml/min as estimated by patient's serum creatinine, weight, and age
* Room air pulse oximetry \>94%
* Patient is not pregnant
* Male and female sexually active patients of reproductive who wish to participate must agree to use acceptable contraception
* Patient is not moribund and has a projected life expectancy \>6 months
* Lansky performance scale \> 70, ECOG \< 2 (Appendix I)
* Potential subjects will be tested for HIV 1 and 2 antibodies, HTLV 1/2 antibodies, and for HIV 1, hepatitis C and hepatitis B virus by NAT testing. - -Subjects testing positive for any of these pathogens will be ineligible for vaccine.
* White blood cells ≥ 2.5 K/µL, Hemoglobin ≥ 8 g/dL, Hematocrit \> 25%, and Platelets ≥ 70 K/µL
* Patient does not have central nervous system involvement.
* Patient does not a have a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis
* Patient is not receiving concurrent systemic steroid therapy
* Patient does not have a known systemic hypersensitivity to imiquimod or any vaccine component