NCT00652899

Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer

MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Allopurinol	All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion.
DRUG	Cyclophosphamide	60 mg/m\^2 on Days 4 and 5 preceding natural killer cell infusion.
DRUG	Fludarabine phosphate	25 mg/m\^2 on Days 6 through 2 preceding natural killer cell infusion.
RADIATION	total-body irradiation	200 cGy Day 1 preceding natural killer cell infusion.
BIOLOGICAL	Allogeneic natural killer cells	Given day 0 - dose of 1.5-8.0 \* 10\^7/kg
BIOLOGICAL	Aldesleukin	10 MU 3 times/week for a total of 6 doses beginning Day 0

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-04-04
• Last updated: 2017-12-28
• Results posted: 2010-09-15

Locations

1 site across 1 country: United States