Trials / Completed
CompletedNCT02130869
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- St. Jude Children's Research Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary Objective: * To evaluate day +35 ANC engraftment in autologous stem cell transplantation for high risk pediatric malignancies after stem cell selection and immunotherapy. Secondary Objectives * To estimate incidence of relapse, disease-free survival and overall survival. * To characterize lymphocyte and hematopoietic reconstitution in these patients. * To describe the characteristics of the stem cell and natural killer cell grafts. * To estimate the overall survival of patients treated without stem cell manipulation or NK cell infusion due to off therapy criteria
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD133+ selected autologous stem cell infusion | Hematopoietic stem cells will be collected from children with high-risk solid tumors. After collection, they will be immuno-magnetically selected using CD133 as a marker in efforts to reduce tumor cell contamination in the stem cell graft. After high dose chemotherapy, those selected stem cells will be infused, followed shortly thereafter by an infusion of haploidentical natural killer cells. |
| BIOLOGICAL | IL-2 | Following infusion of haploidentical natural killer cells, interleukin-2 (IL-2) subcutaneously (SQ) will be given to support the in vivo survival of donor NK cells. |
| BIOLOGICAL | hu14.18K322A | Participants with neuroblastoma (Group A) will receive hu14.18K322A intravenously (IV). |
| DRUG | Busulfan | Given IV - Group A only. |
| DRUG | Melphalan | Given IV - All groups. |
| BIOLOGICAL | GM-CSF | Given SQ - All groups. |
| DRUG | Bendamustine | Given IV - Group B only. |
| DRUG | Etoposide | Given IV - Group B and Group C. In case of etoposide reactions, etoposide phosphate will be given. |
| DRUG | Cytarabine | Given IV - Group B only. |
| DRUG | Carboplatin | Given IV - Group C only. |
| DEVICE | Haploidentical natural killer cell infusion | NK cell product will be collected from donors using leukapheresis procedures. The autologous hematopoietic stem cell graft product will be positively selected using the investigational CliniMACS device and CD133 Microbead reagent. Following standard laboratory procedures, the NK cell product will be enumerated and assessed for viable cell content. NK cells will be infused by slow IV push over 3 to 15 minutes immediately after processing, evaluation and release testing. |
| BIOLOGICAL | G-CSF | Given SQ - All Groups. |
| DRUG | Etoposide phosphate | In case of etoposide reactions, etoposide phosphate will be given IV. - Group B and Group C only. |
| DEVICE | CliniMACS | The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells. |
Timeline
- Start date
- 2014-10-10
- Primary completion
- 2017-12-20
- Completion
- 2017-12-20
- First posted
- 2014-05-06
- Last updated
- 2017-12-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02130869. Inclusion in this directory is not an endorsement.