Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 November 2012
• Main ID: NCT01105650
• Date of registration: 14/04/2010
• Primary sponsor: Masonic Cancer Center, University of Minnesota
• Public title: Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer
• Scientific title: 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)
• Date of first enrolment: July 2010
• Target sample size: 43
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01105650
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Sarah Cooley, MD

• Name: Sarah Cooley, MD

• Name: Sarah Cooley, MD
• Affiliation: Masonic Cancer Center, University of Minnesota

Key inclusion & exclusion criteria

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).

OR

- 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
agent

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
eligible.

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cancer

Intervention(s)

Biological: Natural killer cells

Drug: Cyclophosphamide

Drug: Cyclosporine

Drug: Fludarabine

Drug: IL-2

Drug: Interleukin-2

Drug: Methylprednisolone

Primary Outcome(s)

Response Rate [Time Frame: Month 3]

Secondary Outcome(s)

Natural Killer (NK) Cell Expansion [Time Frame: Day 14]

Overall Survival [Time Frame: 1 Year]

Time to Disease Progression [Time Frame: 1 Year]

Secondary ID(s)

1003M78876

2009LS142

MT2009-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors