Rhabdomyosarcoma Clinical Trial
Official title:
Pilot Study of Expanded , Activated Haploidentical Natural Killer Cell Infusions for Sarcomas
Progress in the treatment of children with leukemia and lymphoma results in high cure rates
but progress in the treatment of children and adolescents with solid tumors has been slow.
Despite aggressive therapy with multimodality treatment involving surgery, radiation and
chemotherapy, about two thirds of the patients with metastatic Ewing sarcoma (EWS), and
intermediate and high risk rhabdomyosarcoma (RMS) will relapse. The available second line
therapies for relapse are limited and often not effective. There is a dire need to look for
treatment options beyond conventional means for the treatment of these patients.
Infusions of allogeneic natural killer (NK) cells in leukemia patients have shown to be
tolerated well without inducing graft versus host disease (GVHD). There is also mounting
evidence that NK cells have activity against solid tumors.
In the lab the investigators tested NK cell activity against cell lines from different
paediatric solid tumors. Among paediatric solid tumors, EWS and RMS are exquisitely sensitive
to killing by expanded NK cells; NK cells also have activity against OS cells. Preliminary
clinical data suggest that donor NK cells may exert antitumor activity in children with solid
tumors undergoing allogeneic hematopoietic stem cell transplantation.
Taking into account the safety of adaptive NK cell infusion, and their efficacy against EWS,
RMS and OS, NK cells could be a powerful new tool in the treatment of paediatric solid
tumors.
The great anti-tumor activity of expanded and activated NK cells, together with the
feasibility of infusing haploidentical NK cells in a non-transplant setting form a compelling
rationale for the clinical testing of these NK cells in patients with sarcoma.
Adoptive transfer of allogeneic NK cells has been shown to be safe in patients with leukemia.
The patients enrolled on this will receive lymphodepleting chemotherapy with cyclophosphamide
(1 day) followed by fludarabine (5 days) Each patient will receive IL-2 on alternate days
starting 1 day before infusion of NK cells for a total of 6 doses.
Patient will undergo imaging MRI or PET or CT scan one month after the infusion to assess
response to the NK cell infusion.
In our study we aim to determine the feasibility, safety and efficacy of expanded, activated
NK cells in patients with EWS and RMS .
We will also study the persistence and phenotype of expanded NK cells in research
participants with EWS and RMS .
The main hypothesis to be tested in this study is that infusion of expanded, activated
haploidentical NK cells can produce measurable clinical responses in patients with EWS and
RMS .
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