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NCT00652899 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-12-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product

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outcome · POSTED

Number of Patients Per Disease Response

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outcome · POSTED

Median Number of Days to Progression

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outcome · POSTED

Median Overall Survival Number of Days Patients Alive After Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    This group includes patients that received all chemotherapy, infusion of natural killer (NK) cells and total body irradiation per protocol. 1\. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m\^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m\^2 on Days 6 through 2 preceding NK cell infusion. 4. Radiation: total-body irradiation 200 cGy Day 1 preceding NK cell infusion. 5. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 \* 10\^7/kg. 6. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0.
    intervention Names
    1. Biological: Allopurinol
    2. Drug: Cyclophosphamide
    3. Drug: Fludarabine phosphate
    4. Radiation: total-body irradiation
    5. Biological: Allogeneic natural killer cells
    6. Biological: Aldesleukin
    label
    Total Body Irradiation
    type
    EXPERIMENTAL
  2. description
    This group includes patients that received chemotherapy and infusion of natural killer cells, but did not receive total body irradiation. 1\. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m\^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m\^2 on Days 6 through 2 preceding NK cell infusion. 4. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 \* 10\^7/kg. 5. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0.
    intervention Names
    1. Biological: Allopurinol
    2. Drug: Cyclophosphamide
    3. Drug: Fludarabine phosphate
    4. Biological: Allogeneic natural killer cells
    5. Biological: Aldesleukin
    label
    No Total Body Irradiation
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. No Total Body Irradiation
    2. Total Body Irradiation
    description
    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.
    name
    Allopurinol
    other Names
    1. Zyloprim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. No Total Body Irradiation
    2. Total Body Irradiation
    description
    60 mg/m\^2 on Days 4 and 5 preceding natural killer cell infusion.
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  3. arm Group Labels
    1. No Total Body Irradiation
    2. Total Body Irradiation
    description
    25 mg/m\^2 on Days 6 through 2 preceding natural killer cell infusion.
    name
    Fludarabine phosphate
    other Names
    1. Fludarabine
    type
    DRUG
  4. arm Group Labels
    1. Total Body Irradiation
    description
    200 cGy Day 1 preceding natural killer cell infusion.
    name
    total-body irradiation
    other Names
    1. TBI
    type
    RADIATION
  5. arm Group Labels
    1. No Total Body Irradiation
    2. Total Body Irradiation
    description
    Given day 0 - dose of 1.5-8.0 \* 10\^7/kg
    name
    Allogeneic natural killer cells
    other Names
    1. related donor haploidentical allogenic cell infusion
    type
    BIOLOGICAL
  6. arm Group Labels
    1. No Total Body Irradiation
    2. Total Body Irradiation
    description
    10 MU 3 times/week for a total of 6 doses beginning Day 0
    name
    Aldesleukin
    other Names
    1. IL-2
    2. Interleukin-2
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Detection of an absolute donor derived cell count of \> or = 100 cells/mL after NK cell infusion.
    measure
    Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
    time Frame
    Day 12-14
secondary Outcomes
  1. description
    Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-\< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- \< or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of \< or = 1 new lesion.
    measure
    Number of Patients Per Disease Response
    time Frame
    1 Month After Natural Killer Cell Infusion (Day 30)
  2. description
    Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) \> or = 20% increase in sum of all target or any new lesions.
    measure
    Median Number of Days to Progression
    time Frame
    From date of first treatment to disease progression
  3. description
    Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored.
    measure
    Median Overall Survival Number of Days Patients Alive After Treatment
    time Frame
    From first date on-study (treatment) to date of death
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
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      offset unit
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      query cond
      Ovarian Germ Cell Tumors
      query disease state id
      ds-ovarian-germ-cell-tumors
      source file
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      source file sha256
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      source kind
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    Preserved source evidence · Not medical advice