Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma

Inclusion Criteria

• •A. Diagnosis
• •rhabdomyosarcoma: embryonal or alveolar.
• •Ewing's sarcoma family of tumors (ESFT), which include: classical, atypical and extraosseous ESFT, peripheral primitive neuroectodermal tumors, peripheral neuroepithelioma, primitive sarcoma of bone, and ectomesenchymoma.
• •neuroblastoma: may be diagnosed via histology or the standard clinical evidence for increased catecholamines in the urine plus tumor cells in the bone marrow.
• •undifferentiated or embryonal sarcoma.
• •desmoplastic small round cell tumor.
• •synovial cell sarcoma.
• •B. Extent of Disease/Previous Therapy
• •Initial presentation: Stage IV or metastatic disease, enrolled prior to any cytoreductive therapy.
• •Recurrent Disease:
• •* Patient \> 5yo must have recovered CD4 count to \> 350 cells/mm\^3 OR have disease free interval \> one year from completion of cytotoxic therapy
• •* Patients \< 5yo must have recovered CD4 count to \> 350 cells/mm\^3 OR have disease free interval \> six months from completion of cytotoxic therapy
• •Multiple recurrences are allowable as long as CD4 count or disease-free intervals have been met.
• •C. Age/Weight
• •greater than 18 mos. and less than or equal to 35 years at the time of initial diagnosis.
• •greater than 10 kg at the time of apheresis. Patients between 10-15 kg must be approved by the apheresis unit prior to enrollment on protocol.
• •D. Informed Consent
• •All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility. After confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility).
• •E. Laboratory Parameters
• •renal function: creatinine clearance greater than 60 mL/min/1.73m\^2 or normal age adjusted serum creatinine (less than or equal to 5 yrs. less than or equal to 0.8 mg/ml; 5-10 yrs. less than or equal to 1.0 mg/ml; 10-15 yrs. less than or equal to 1.2 mg/ml; greater than 15 yrs. less than or equal to 1.5 mg/ml)
• •liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times upper limit of normal (ULN), bilirubin less than 1.5 ULN
• •hematologic function: platelets greater than 50,000 cells/mcl, hemoglobin (Hgb) greater than 9.0 gms/dl, prothrombin time (PT) less than 1.5 ULN. Patients may receive transfusion if necessary to reach the pre-apheresis hematology parameters.
• •F. Accessibility of Tissue to Generate Tumor Lysates
• •National Cancer Institute (NCI) Laboratory of Pathology will review all tumor specimens for diagnosis.
• •A. Informed Consent
• •Because significant time will have elapsed between apheresis/tumor biopsy and the initiation of immunotherapy, all patients or their legal guardians (if the patient is less than 18 years old) must sign a second informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility).
• •B. Time and Recovery from Cytotoxic Therapy
• •At least 3 weeks should have elapsed since the last cycle of cytotoxic therapy or since the last dose of radiation therapy, at least 4 weeks must have elapsed since the patient has received any investigational therapy, and patients should have recovered from toxic side effects of previous therapy to a grade 1 or less, with the exception of the following:
• •Hematological toxicity: recovery to levels required in Section 2.1.1.E.
• •Low electrolyte levels (Such individuals should receive appropriate supplementation).
• •For patients on anticoagulant therapy or with pre-existing coagulation abnormalities, prothrombin time (PT), partial thromboplastin time (PTT) must return to baseline.
• •Liver function tests must resolve to values required in Section 2.1.1.E.
• •Grade 3 hypoalbuminemia.
• •Alopecia.
• •Sterility.
• •C. Laboratory Parameters
• •renal function: creatinine clearance greater than 60 mL/min/1.73m\^2 or normal age adjusted serum creatinine (less than or equal to 5 yrs. less than or equal to 0.8 mg/ml; 5-10 yrs. less than or equal to 1.0 mg/ml; 10-15 yrs. less than or equal to 1.2 mg/ml; greater than 15 yrs. less than or equal to 1.5 mg/ml).
• •liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times upper limit of normal (ULN), bilirubin less than 1.5 ULN.
• •hematologic function: absolute neutrophil count (ANC) greater than 750 cells/mcl, platelets greater than 50,000 cells/mcl.
• •D. Birth Control
• •Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.