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Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30)

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Breast Cancer

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Trial Information

Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30)

The donor NK cells are infused on day 0, after a non-myeloablative preparative regimen of
cyclophosphamide and fludarabine plus a cyclosporine A (CsA) based immunosuppressive
therapy. Subcutaneous interleukin-2 (IL-2) is started the evening of the NK infusion and
continued three times a week for 6 doses total.

Up to 4 sequential immunosuppressive platforms will be tested (Arms 1 and 2 are currently
closed) to identify a platform where patients have the potential for successful NK cell
expansion (defined as an absolute circulating donor derived NK cell count of > 100 cells/μl
14 days after NK cell infusion). Once a clinical platform is determined, the platform will
be expanded to a total of 18 patients. The primary goal of this extended phase is to obtain
preliminary efficacy information.

Follow-up for disease response is for 1 year from the NK cell infusion, with the possibility
of re-treatment for patients who experience at least a clinical benefit who progress after 6

Inclusion Criteria:

- Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer
that has failed or progressed after at least 2 prior salvage chemotherapy regimens
(directed at recurrent/metastatic disease).


- Diagnosis of metastatic breast cancer (female or male) that has progressed on or
failed at least one salvage chemotherapy regimen for metastatic disease and that
meets the following disease specific related criteria:

- If estrogen receptor or progesterone receptor positive must have progressed on
prior hormonal therapy and/or

- if HER2-neu positive must have progressed on trastuzumab, lapatinib, or similar

Women with a history of both cancers are eligible for this study provided that they
currently meet eligibility for one of the diseases. Women who have had another malignancy
and have been disease free for at least 3 year, or with a history of completely resected
non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.

- Measurable disease per disease specific Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1 - patients with bone as their only site of disease will not be

- If history of brain metastases must be 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 clinical signs or
symptoms suggestive of brain metastases.

- Available related HLA-haploidentical natural killer (NK) cell donor (by at least
class I serologic typing at the A&B locus)

- Age 18 years or older

- Karnofsky performance status > or = 50%

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

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

- Renal function: creatinine (Cr) < or = 2.0 mg/dL

- Liver function: Aspartate aminotransferase (AST), Alanine transaminase (ALT), total
bilirubin, alkaline phosphatase < 5 times upper limit of institutional normal (ULN)

- Cardiac: Left ventricular ejection fraction >40% (within 28 days of treatment start)

- 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 is acceptable (within 28 days of
treatment start)

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

- At least 14 days must lapse between last prior anti-cancer treatment and 1st day of
preparative regimen

- Voluntary written informed consent

Exclusion Criteria:

- Pregnant or nursing - 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. Participants of
childbearing potential must have a blood test or urine study within 14 days prior to
registration to rule out pregnancy and agree to use adequate birth control during
study treatment

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

Disease response demonstrated by using standard response criteria (RECIST) (Stable Disease (SD) + Partial Response (PR) + Complete Response (CR) after haploidentical donor NK cell infusion in patients with recurrent ovarian or breast cancer.

Outcome Time Frame:

Month 3

Safety Issue:


Principal Investigator

Sarah Cooley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

June 2014

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Breast Cancer
  • recurrent ovarian cancer
  • recurrent fallopian tube cancer
  • recurrent primary peritoneal cancer
  • refractory ovarian cancer
  • refractory fallopian tube cancer
  • refractory peritoneal cancer
  • metastatic breast cancer
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455