Activated T Cells Armed With GD2 Bispecific Antibody in Children and Young Adults With Neuroblastoma and Osteosarcoma

The study is now in the phase II expansion phase.

Inclusion Criteria for phase II:

* The target tumor is limited to neuroblastoma and the diagnosis should be histologically verified.
* Patients must have refractory or recurrent malignancy; patient's current disease state must be one for which no known curative therapy is available;
* Patients should not receive any other experimental or phase 1 therapy within 3 weeks prior to study enrollment and monoclonal antibody therapy within 6 weeks
* To be eligible for phase I study patients should have primary refractory or relapsed disease as evidenced by:

  * Local tumor recurrence measurable on CT or magnetic resonance imaging (MRI) scans with or without metastatic lesions
  * Refractory bone marrow involvement in patients with NB
  * NB with MIBG-positive skeletal lesions
* 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);
* 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:
* Patients must have a Lansky or Karnofsky performance status score of \>= 70
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy

  * Myelosuppressive chemotherapy: must not have received within 3 weeks of starting immunotherapy (IT)
  * Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy
  * Immunotherapy: at least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody
* Normal organ function
* 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
* 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