Clinical trial NCT00652899 (phase 2, status: terminated)
Conditions: fallopian tube cancer, ovarian cancer, peritoneal cavity cancer
ICD codes: C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: cyclophosphamide, fludarabine phosphate
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Reason stopped: 
    withdrawn due to toxicity
  
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer
             who meets the following criteria:

          -  Measurable disease (≥ 1 cm) per Response Evaluation Criteria for Solid Tumors (RECIST)
             - patients with bone as their only site of metastatic disease will not be eligible

          -  Progression on or failure to respond to at least 2 salvage chemotherapy regimens (2
             regimens given for disease recurrence) for recurrent/metastatic ovarian, fallopian
             tube, or primary peritoneal cancer

          -  If history of brain metastases, stable for at least 3 months after treatment - A brain
             computed tomography (CT) scan will only be required in subjects with known brain
             metastases at the time of enrollment or in subjects with new clinical signs or
             symptoms suggestive of brain metastases.

          -  Available related HLA-haploidentical natural killer (NK) cell donor (by at least class
             I serologic typing). If biologic parents or siblings are available, can proceed with
             work-up of subject prior to return of human leukocyte antigen (HLA) typing results.

          -  Age 18 years or older

          -  Gynecology Oncology Group (GOG) performance status 0 or 1

          -  Adequate organ function as determined by the following criteria within 14 days of
             study enrollment:

               -  Bone marrow: platelets ≥ 80,000 x 10^9/L and hemoglobin ≥ 9g/dL, unsupported by
                  transfusions; absolute neutrophil count (ANC) ≥ 1000 x 10^9/L, unsupported by
                  granulocyte-colony stimulating factor (G-CSF) or granulocyte macrophage-colony
                  stimulating factor (GM-CSF)

               -  Renal function: creatinine (Cr) ≤ 2.0 mg/dL

               -  Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT),
                  total bilirubin, alkaline phosphatase < 5 times upper limit of institutional
                  normal

               -  Cardiac: Left ventricular ejection fraction >40%

               -  Pulmonary function: > 50% corrected Carbon Monoxide Diffusing Capacity (DLCO) and
                  Forced expiratory volume in one second (FEV1), if presence of pleural effusion
                  due to metastatic disease >40% corrected DLCO and FEV1 acceptable.

          -  Able to be off prednisone or other immunosuppressive medications for at least 3 days
             prior to Day 0

          -  Voluntary written informed consent signed before performance of any study related
             procedure not part of normal medical care.

        Exclusion Criteria:

          -  Pregnant or lactating - The agents used in this study may be teratogenic to a fetus
             and there is no information on the excretion of agents into breast milk. All females
             of childbearing potential must have a blood test or urine study within 14 days prior
             to registration to rule out pregnancy.

          -  Active infection - subjects must be afebrile, off antibiotics, and with no
             uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or
             biopsies are allowed).

        Human anti-mouse antibody (HAMA) monitoring: All subjects will be questioned about prior
        exposure to antibody therapy (including OKT3, Rituximab, Trastuzumab, etc). Responses will
        be recorded and reported to the FDA as part of the annual report. For subjects with no
        prior antibody therapy exposure, no further action will be taken. For subjects who have
        received previous antibody therapies 10 ml of serum (red top tube) will be drawn before
        starting therapy and banked per section 8.1. The presence of HAMA will not exclude a
        patient from the study.