• In vivo expansion of an infused allogeneic natural killer cell product [ Designated as safety issue: No ]
  

• Safety and toxicity [ Designated as safety issue: Yes ]
  
• Disease response (complete or partial response) or clinical benefit (stable disease for > 6 months) as measured by RECIST criteria [ Designated as safety issue: No ]
  
• Time to progression [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Association between clinical response and donor/recipient KIR ligand matching status [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell product following a preparative regimen comprising cyclophosphamide and fludarabine phosphate in treating patients with recurrent and/or metastatic ovarian 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 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 and cyclophosphamide IV on days -5 and -4.
• Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive aldesleukin-activated haploidentical allogeneic NK cells 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 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.

DISEASE CHARACTERISTICS:

• Diagnosis of ovarian cancer

  • Recurrent and/or metastatic disease
• Measurable disease, defined as ≥ 1.0 cm by RECIST criteria
• Disease progression during or failed to respond to ≥ 2 prior salvage chemotherapy regimens for recurrent and/or metastatic ovarian cancer

• History of brain metastases allowed provided they have been stable for ≥ 3 months after treatment

  • A brain CT scan is required for patients with known brain metastases or with new clinical signs or symptoms of brain metastases at time of study enrollment
• No bone-only metastatic disease
• Related HLA-haploidentical natural killer cell donor available (by at least class I serologic typing)

PATIENT CHARACTERISTICS:

• GOG performance status 0-1
• ANC ≥ 1,000 x 10^9/L
• Platelet count ≥ 80,000 x 10^9/L
• Hemoglobin ≥ 9 g/dL
• Creatinine ≤ 2.0 mg/dL
• Bilirubin ≤ 3.0 mg/dL
• AST and ALT < 5 times upper limit of normal (ULN)
• Alkaline phosphatase < 5 times ULN
• LVEF > 40% (testing required only if symptomatic or prior known impairment)
• Corrected DLCO and FEV_1 > 50% (testing required only if symptomatic or prior known impairment)

• No active infection

  • Must be afebrile, off antibiotics, and have no uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or biopsies after clinically appropriate testing are allowed)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 3 days since prior prednisone or other immunosuppressive medications