Ovarian Cancer Clinical Trial
Official title:
MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body
irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells.
It also helps stop the patient's immune system from rejecting the donor's natural killer
cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or
primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may
help the natural killer cells kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural
killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine,
and total-body irradiation in treating patients with recurrent and/or metastatic ovarian,
fallopian tube, or primary peritoneal cancer.
OBJECTIVES:
Primary
- To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell
product following a preparative regimen comprising cyclophosphamide, fludarabine
phosphate, and total-body irradiation in treating patients with recurrent and/or
metastatic ovarian, fallopian tube, or primary peritoneal cancer.
Secondary
- To characterize the quantitative and qualitative toxicities of this treatment regimen.
- To estimate disease response (complete or partial response) or clinical benefit (stable
disease for > 6 months) as measured by Response Evaluation Criteria in Solid Tumours
(RECIST) criteria.
- To estimate time to progression and overall survival.
- To estimate the association between clinical response and donor/recipient KIR ligand
matching status.
Tertiary
- To evaluate immune activation of the in vivo expanded haploidentical allogeneic NK cells
and its effect on the immune system.
OUTLINE:
- Preparative regimen: Patients receive fludarabine phosphate IV on days 6 to 2 preceding
natural killer (NK) cell infusion and cyclophosphamide IV on days 5 and 4 preceding NK
cell infusion. Patients also undergo total-body irradiation on day 1 preceding NK cell
infusion.
- Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive
aldesleukin-activated haploidentical allogeneic NK cells intravenously (IV) on day 0.
Beginning 4-6 hours after allogeneic NK cell infusion, patients receive aldesleukin
subcutaneously (SC) 3 times a week for 6 doses.
Patients achieving any initial response (complete or partial response) or a clinical benefit
(stable disease for > 6 months) who progress after 6 months may receive 1 re-treatment course
as above.
Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3 months
post NK cell infusion for cytokine measurements, immunophenotyping, functional analyses, and
testing for persistence of donor cells.
After completion of study treatment, patients are followed periodically for at least 1 year.
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