Ovarian CancerPhase 2NCT01105650
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer
A Phase 2 study testing Fludarabine, Cyclophosphamide and Cyclosporine in people with Ovarian Cancer and Fallopian Tube Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a single center phase II trial designed to optimize a clinical platform of lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian, fallopian tube, primary peritoneal cancer and advanced… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Fludarabine, Cyclophosphamide and Cyclosporine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official 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)
This is a single center phase II trial designed to optimize a clinical platform of lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian, fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.
Read the detailed description
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 months.
- Being tested
- Fludarabine, Cyclophosphamide, Cyclosporine, Natural killer cells, IL-2
- Keywords
- recurrent ovarian cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cancer, refractory ovarian cancer, refractory fallopian tube cancer, refractory peritoneal cancer, metastatic breast cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludara
Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
CyclophosphamideDrug
Also called Cytoxan
Administered intravenously, 60 mg/kg, days -5 and -4.
CyclosporineDrug
Also called Cyclosporine A, CsA
Administered intravenously, CsA 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Natural killer cellsBiological
Administered by infusion over less than 1 hour, no more than 8.0 x 10^7 cells/kg will be given.
IL-2Drug
Also called Interleukin-2
Will be given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 5 million units/m^2 3 times per week for 6 doses).
Also called Medrol
Administered intravenously (IV) 10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9
Also called Medrol
Administered intravenously (IV) 1 mg/kg Days -2 to +9
Interleukin-2Drug
Also called IL-2
Will be given subcutaneously at million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 3 million units/m^2 3 times per week for 6 doses).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CsA | Experimental | Patients receiving Cyclosporine (CsA) and Natural Killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Cyclosporine; Biological: Natural killer cells; Drug: IL-2; Drug: Interleukin-2 |
| Arm 2: CsA plus Methylprednisolone (10mg) | Experimental | Patients receiving Cyclosporine (CsA), methylprednisolone and natural killer cells (NK) infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Cyclosporine; Biological: Natural killer cells; Drug: IL-2; Drug: Methylprednisolone; Drug: Interleukin-2 |
| Arm 3: CsA plus Methylprednisolone (1 mg) | Experimental | Patients receiving Cyclosporine (CsA), methylprednisolone and natural killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Cyclosporine; Biological: Natural killer cells; Drug: IL-2; Drug: Methylprednisolone; Drug: Interleukin-2 |
| Arm 4: CsA minus Methylprednisolone | Experimental | Patients receiving Cyclosporine (CsA), no methylprednisolone, eliminating IL-2 doses 4-6 and receiving Natural Killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 3 doses given post NK cell infusion. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Cyclosporine; Biological: Natural killer cells; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.
Measured: Month 3
Secondary outcomes (3)
Time to Disease Progression
Time from study entry until progressive disease or data collection cutoff.
Measured: 1 Year
Number of Participants With Progressive Disease at One Year
Measured: 1 Year
Overall Survival
Number of participants alive at 1 year.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Geller, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105650
- Sponsor's protocol ID
- 2009LS142
- Other IDs
- MT2009-30, 1003M78876
- Status last verified
- Dec 2017
- First submitted
- 14 Apr 2010
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT01105650
- Acronym / sponsor ID
- 2009LS142
- Keywords
- recurrent ovarian cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cancer, refractory ovarian cancer, refractory fallopian tube cancer, refractory peritoneal cancer, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Posted 24 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center phase II trial designed to optimize a clinical platform of lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian, fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.
Detailed description
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 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CsA | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Cyclosporine, Biological: Natural killer cells, Drug: IL-2, Drug: Interleukin-2Patients receiving Cyclosporine (CsA) and Natural Killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion. |
| Arm 2: CsA plus Methylprednisolone (10mg) | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Cyclosporine, Biological: Natural killer cells, Drug: IL-2, Drug: Methylprednisolone, Drug: Interleukin-2Patients receiving Cyclosporine (CsA), methylprednisolone and natural killer cells (NK) infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion. |
| Arm 3: CsA plus Methylprednisolone (1 mg) | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Cyclosporine, Biological: Natural killer cells, Drug: IL-2, Drug: Methylprednisolone, Drug: Interleukin-2Patients receiving Cyclosporine (CsA), methylprednisolone and natural killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion. |
| Arm 4: CsA minus Methylprednisolone | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Cyclosporine, Biological: Natural killer cells, Drug: Interleukin-2Patients receiving Cyclosporine (CsA), no methylprednisolone, eliminating IL-2 doses 4-6 and receiving Natural Killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 3 doses given post NK cell infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineAlso: FludaraAdministered intravenously, 25 mg/m^2, days -6 through -2 (5 days). | Drug | Arm 1: CsA, Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg), Arm 4: CsA minus Methylprednisolone |
| CyclophosphamideAlso: CytoxanAdministered intravenously, 60 mg/kg, days -5 and -4. | Drug | Arm 1: CsA, Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg), Arm 4: CsA minus Methylprednisolone |
| CyclosporineAlso: Cyclosporine A, CsAAdministered intravenously, CsA 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14 | Drug | Arm 1: CsA, Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg), Arm 4: CsA minus Methylprednisolone |
| Natural killer cellsAdministered by infusion over less than 1 hour, no more than 8.0 x 10^7 cells/kg will be given. | Biological | Arm 1: CsA, Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg), Arm 4: CsA minus Methylprednisolone |
| IL-2Also: Interleukin-2Will be given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 5 million units/m^2 3 times per week for 6 doses). | Drug | Arm 1: CsA, Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg) |
| MethylprednisoloneAlso: MedrolAdministered intravenously (IV) 10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9 | Drug | Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg) |
| MethylprednisoloneAlso: MedrolAdministered intravenously (IV) 1 mg/kg Days -2 to +9 | Drug | Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg) |
| Interleukin-2Also: IL-2Will be given subcutaneously at million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 3 million units/m^2 3 times per week for 6 doses). | Drug | Arm 1: CsA, Arm 2: CsA plus Methylprednisolone (10mg), Arm 3: CsA plus Methylprednisolone (1 mg), Arm 4: CsA minus Methylprednisolone |
Primary outcome
Response Rate
Time frame: Month 3
Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.
3 secondary outcomes
Time to Disease Progression
Time frame: 1 Year
Number of Participants With Progressive Disease at One Year
Time frame: 1 Year
Overall Survival
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Geller, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Cyclophosphamide and Cyclosporine in people with Ovarian Cancer and Fallopian Tube Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.