OKT3/Humanized 3F8 Bispecific Antibody-Activated T Lymphocytes, Aldesleukin, and Sargramostim in Treating Younger Patients with GD2-Positive Metastatic, Recurrent or Refractory Solid Tumors

Inclusion Criteria

• The target tumor is limited to neuroblastoma and other GD2-positive solid tumors; diagnosis should be histologically verified at Children’s Hospital of Michigan (CHM) or Memorial Sloan Kettering Cancer Center (MSKCC)
• Assessment of GD2 status is not required for NB or for other tumors known to express GD2 in 70% or more of cases: specifically osteosarcoma (GD2 expressed in 88%), spindle cell sarcoma (93%) and desmoplastic small round cell tumor (DSRCT) (70%); all other non-NB tumors will require confirmation of GD2 expression on cell surface by immunohistochemistry on fresh frozen tissue that will be performed at MSKCC; patients with suspected GD2-positive tumors (other than osteosarcoma, spindle cell sarcoma or DSRCT) will have their tumors assessed after obtaining a separate informed consent for this purpose
• Patients must have disease refractory to standard therapy or recurrent malignancy; patient’s current disease state must be one for which no known curative therapy is available; to be eligible for phase I study patients should have primary refractory or relapsed disease as evidenced by either: * Local or/and metastatic tumor recurrence or primary refractory tumor measurable on CT or magnetic resonance imaging (MRI) scans * Refractory persistent bone marrow disease with evidence of NB involvement of bone marrow in at least one site of biopsy * NB with metaiodobenzylguanidine (MIBG)-positive skeletal lesions (at least one site) * For sarcoma patients with resected pulmonary lesions pre-surgery CT scans demonstrating disease are required
• The presence of radiographically measurable disease immediately prior to start of Phase I immunotherapy is not an eligibility requirement in the following situations: * In patients with NB who have documented bone marrow (BM) involvement; * In patients with NB who have MIBG-positive bony lesion(s); * In patients with OST who had to undergo resection of the pulmonary lesion(s)
• An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement: * Measurable disease is defined as the presence of at least one solid lesion on MRI or CT scan that can be accurately measured with the longest diameter of at least 10 mm in at least one dimension * Patients with NB who do not have measurable soft tissue disease but have MIBG-positive evaluable skeletal disease are eligible for phase II study * Patients with NB who have evidence of tumor cells in bone marrow are eligible for phase II study
• Patients must have a Lansky or Karnofsky performance status score of >= 70; Karnofsky system will be used for patients > 16 years of age and Lansky system for patients < 16 years of age
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy * Myelosuppressive chemotherapy: must not have received chemotherapy within 2 weeks of enrollment and within 2 week of starting protocol therapy * Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy for both enrollment on study and for commencement of protocol therapy * Immunotherapy: patients may not have received immunotherapy within 3 weeks of enrollment and within 6 weeks of commencing protocol therapy
• Absolute neutrophil count (ANC) >= 500/mm^3 (patients should be off granulocyte colony-stimulating factor [G-CSF] for at least 7 days)
• Platelet count >= 50,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment); in NB patients with known bone marrow involvement relaxed platelet count eligibility requirement should be used: a platelet count of >= 20,000/mm that can be maintained with =< 1 platelet transfusion per week
• Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
• Absolute lymphocyte count >= 500/mm^3
• Serum creatinine =< 1.5 x upper limit of normal or a creatinine clearance or glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2
• Shortening fraction >= 28% by echocardiogram or ejection fraction >= 50% by echocardiogram or radionuclide study
• Total bilirubin =< 1.5 x upper limit of normal
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal; for the purpose of this study, the upper limit of normal (ULN) for SGPT is 45 U/L
• All patients or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria

• Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are postmenarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy and for 3 months after the last dose of GD2Bi-aATC; breastfeeding women should be excluded
• Concomitant medication restrictions * Growth factor(s): growth factors that support platelet or white cell number or function must not have been administered within 7 days prior to enrollment (14 days if Neulasta) * Corticosteroids: patients requiring corticosteroids should not be on a chronic dose; patients should be off steroid for at least 14 days prior to immunotherapy (IT) and they should not receive steroids during protocol treatment * Investigational drugs: patients who are currently receiving another investigational drug are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible