A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas
Summary
This is a pilot clinical trial investigating the addition of haploidentical natural killer cell infusion to autologous stem cell transplantation. This intervention will be evaluated in children with high-risk solid tumors for whom autologous transplantation is indicated. Natural killer cells from a haploidentical family member will be given after high dose chemotherapy and positively selected autologous stem cells. In patients with neuroblastoma, the anti-GD2 antibody hu14.18K322A will also be given. The effect on normal hematopoietic cell recovery will be evaluated and survival of children treated with this approach will be determined. The investigators expect to enroll 36 participants. Haploidentical family members (donors) will also be recruited to provide natural killer cells.
Timeline
- Start
- 2014-10-10
- Primary completion
- 2017-12-20
- Completion
- 2017-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | — | Intravenous |
| Background | Bendamustine | Small molecule | — | Intravenous |
| Background | Busulfan | Small molecule | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Etoposide | Small molecule | — | Intravenous |
| Background | G-CSF | Unknown | — | Subcutaneous |
| Background | Melphalan | Small molecule | — | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | Subcutaneous |
| Background | sargramostim | Protein / enzyme biologic | — | Subcutaneous |