Locally Advanced Adrenal Gland PheochromocytomaPhase 2NCT04106843
Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers
A Phase 2 study testing Lutetium Lu 177 Dotatate in people with Locally Advanced Adrenal Gland Pheochromocytoma and Locally Advanced Paraganglioma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well 177Lu-DOTATATE works in treating patients with rare endocrine cancers that have spread from where they started to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Adrenal Gland Pheochromocytoma, Locally Advanced Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma
- What is being tested?
- Lutetium Lu 177 Dotatate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2019to 3 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of PHPG, MTC, parathyroid or pituitary tumor
- Locally advanced or distantly metastatic disease not amenable to surgery
- Patients should have somatostatin receptor (SSTR)+ tumor as determined by 68Ga-DOTATATE PET/CT imaging. A measurable SSTR+ tumor is defined as having greater than or equal to 10 mm in diameter with uptake higher than or equal to liver and is qualitatively higher and distinguishable from background activity
- In patients with multiple lesions (more than one) as determined by staging CT or MRI, the number of SSTR+ lesions should be more than or equal to the number of SSTR- lesions
- Patients enrolled in cohorts 1-4 should have measurable disease defined by RECIST 1.1
- Patients enrolled in cohort 5 should have non-measurable disease as defined by RECIST 1.1
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- Progressive disease per RECIST 1.1 as determined by the investigator within the 12 months preceding study enrollment
- Radiographic assessment of all known disease sites, e.g., by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate within 28 days before the first dose of (177)Lu-DOTATATE
- Disease specific hormonal studies to assess abnormal hormonal secretion within 28 days before the first dose of (177)Lu-DOTATATE. These studies may include the following: plasma metanephrines and catecholamines for PHPG, calcitonin and CEA for MTC, prolactin for malignant prolactinomas, IGF-1 for growth hormone secreting malignant somatotropinomas, ACTH for malignant corticotropinomas, intact parathyroid hormone for parathyroid carcinomas
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Life expectancy of at least 6 months
- Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Platelets >= 100,000/mm^3 (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Hemoglobin >= 9 g/dL (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Bilirubin =< 1.5 x the upper limit of normal (ULN) (within 4 days prior to the first dose of [177]Lu-DOTATATE). For subjects with known Gilbert's disease, bilirubin =< 3.0 mg/dL
- Serum albumin >= 2.8 g/dl (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 50 mL/min (within 4 days prior to the first dose of [177]Lu-DOTATATE). For creatinine clearance estimation, the Cockcroft and Gault equation should be used
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Random urine protein/creatinine ratio (UPCR) =< 1 (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Serum phosphorus, calcium, magnesium and potassium >= lower limit of normal (LLN) (within 4 days prior to the first dose of [177]Lu-DOTATATE)
- Capable of understanding and complying with the protocol requirements and has signed the informed consent document
- Sexually active patients (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 6 months after the last dose of study drug(s)
- Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea >= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason
Who cannot join
- Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., somatostatin analogues, cytokines or antibodies) within 12 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment. For patients with acromegaly, Cushing disease, and thyroid-stimulating hormone (TSH) secreting pituitary carcinomas treatment with somatostatin analogues is allowed
- Prior treatment with (177)Lu-DOTATATE or other radionuclide agents (e.g. (131)I meta-iodobenzylguanidine, (131)I Ultratrace Iobenguane)
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
- Prior treatment of any small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment
- Receipt of any other type of investigational agent within 28 days before the first dose of study treatment
- The subject has not recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
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- Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
- Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders including
- Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
- Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
- Any of the following within 6 months before the first dose of study treatment:
- Unstable angina pectoris
- Clinically-significant cardiac arrhythmias
- Stroke (including transient ischemic attack (TIA), or other ischemic event)
- Myocardial infarction
- Other clinically significant disorders such as:
- Active infection requiring systemic treatment within 28 days before the first dose of study treatment
- Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
- History of organ transplant
- Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment; in patients with central hypothyroidism due to pituitary cancer FT4 should be within normal limits, TSH is not evaluable for this cohort
- Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
- Pregnant or breastfeeding
- A previously identified allergy or hypersensitivity to components of the study treatment formulation
- Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
- Evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or papillary microcarcinoma as long as there is no evidence of disease
- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the patient inappropriate for entry into this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study to Evaluate the Effects of 177Lu-DOTATATE in Patients With Unresectable and Progressive Rare Metastatic Endocrine Carcinomas: Medullary Thyroid Cancer, Parathyroid Carcinoma, Pituitary Carcinoma, and Malignant Pheochromocytoma/Paraganglioma
This phase II trial studies how well 177Lu-DOTATATE works in treating patients with rare endocrine cancers that have spread from where they started to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Radioactive drugs, such as 177Lu-DOTATATE, may carry radiation directly to cancer cells and not harm normal cells. 177Lu-DOTATATE may help to control endocrine cancers compared to standard treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by Ia. Computed tomography (CT) or Ib. Magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
- To estimate progression-free survival at 1-year. II. To correlate blood pressure control and change/discontinuation of antihypertensive medications with tumor responses in patients with pheochromocytomas and paragangliomas (PHPGs).
III. To correlate plasma metanephrines and chromogranin A with tumor responses in patients with PHPGs.
IV. To correlate calcitonin, carcinoembryonic antigen, and chromogranin A with tumor responses in patients with medullary thyroid carcinoma (MTCs).
- To correlate pituitary hormones (depending on particular tumor, e.g. prolactin for prolactinomas, insulin-like growth factor (IGF-1) for acromegaly, adrenocorticotropic hormone (ACTH) and 24-hour urine free cortisol for Cushing disease, and chromogranin A with tumor responses in patients with functional pituitary carcinomas).
VI. To correlate calcium, intact parathyroid hormone (iPTH), and chromogranin A with tumor responses in patients with parathyroid carcinoma.
VII. Toxicity assessment by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0).
VIII. To correlate tumor responses with tumor uptake score in somatostatin receptor scintigraphy, overall prognosis and responsiveness to lutetium Lu 177 dotatate (177Lu-DOTATATE).
IX. To determine the percentage of tumors that demonstrate uptake on diagnostic 68Gallium-DOTATATE positron emission tomography (PET)/CT that would make treatment with 177Lu-DOTATATE feasible.
EXPLORATORY OBJECTIVES:
- To evaluate pituitary function in all patients to look for possible radiation late effects on the pituitary gland.
II. To estimate best biochemical response for specific tumor markers in patients with non-measurable disease.
III. To correlate biochemical response in patients with non-measurable disease with RECIST 1.1 tumor response criteria for patients with non-measurable disease.
OUTLINE:
Patients receive 177Lu-DOTATATE intravenously (IV) over 30 minutes every 8-16 weeks. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at week 72 and then every 24 weeks for up to 5 years.
- Conditions
- Locally Advanced Adrenal Gland Pheochromocytoma, Locally Advanced Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma, Metastatic Paraganglioma, Metastatic Parathyroid Gland Carcinoma, Pituitary Gland Carcinoma
- Being tested
- Lutetium Lu 177 Dotatate
- Medical subject headings
- Pheochromocytoma, Paraganglioma, Parathyroid Neoplasms, Pituitary Neoplasms, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium Lu 177 DotatateDrug
Also called 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (177Lu-DOTATATE) | Experimental | Patients receive 177Lu-DOTATATE IV over 30 minutes every 8-16 weeks. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Lutetium Lu 177 Dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by computed tomography (CT) or magnetic resonance imaging (MRI). Will be calculated as the proportion of patients with complete responses (CR), partial responses (PR), or stable disease (SD) at the CT/MRI assessment time point.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start13 Jun 2019 (estimated)
- Primary completion3 Sep 2020
- Study completion3 Sep 2020
Why it stopped: No Participants Registered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Adrenal Gland PheochromocytomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Camilo Jimenez, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106843
- Sponsor's protocol ID
- 2018-0947
- Other IDs
- NCI-2019-05859, 2018-0947
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Effects of 177Lu-DOTATATE in Patients With Unresectable and Progressive Rare Metastatic Endocrine Carcinomas: Medullary Thyroid Cancer, Parathyroid Carcinoma, Pituitary Carcinoma, and Malignant Pheochromocytoma/Paraganglioma
- ClinicalTrials.gov ID
- NCT04106843
- Acronym / sponsor ID
- 2018-0947
- Conditions
- Locally Advanced Adrenal Gland Pheochromocytoma, Locally Advanced Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma, Metastatic Paraganglioma, Metastatic Parathyroid Gland Carcinoma, Pituitary Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Registered
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jun 2019 (estimated)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well 177Lu-DOTATATE works in treating patients with rare endocrine cancers that have spread from where they started to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Radioactive drugs, such as 177Lu-DOTATATE, may carry radiation directly to cancer cells and not harm normal cells. 177Lu-DOTATATE may help to control endocrine cancers compared to standard treatment.
Detailed description
PRIMARY OBJECTIVE:
- Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by Ia. Computed tomography (CT) or Ib. Magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
- To estimate progression-free survival at 1-year. II. To correlate blood pressure control and change/discontinuation of antihypertensive medications with tumor responses in patients with pheochromocytomas and paragangliomas (PHPGs).
III. To correlate plasma metanephrines and chromogranin A with tumor responses in patients with PHPGs.
IV. To correlate calcitonin, carcinoembryonic antigen, and chromogranin A with tumor responses in patients with medullary thyroid carcinoma (MTCs).
- To correlate pituitary hormones (depending on particular tumor, e.g. prolactin for prolactinomas, insulin-like growth factor (IGF-1) for acromegaly, adrenocorticotropic hormone (ACTH) and 24-hour urine free cortisol for Cushing disease, and chromogranin A with tumor responses in patients with functional pituitary carcinomas).
VI. To correlate calcium, intact parathyroid hormone (iPTH), and chromogranin A with tumor responses in patients with parathyroid carcinoma.
VII. Toxicity assessment by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0).
VIII. To correlate tumor responses with tumor uptake score in somatostatin receptor scintigraphy, overall prognosis and responsiveness to lutetium Lu 177 dotatate (177Lu-DOTATATE).
IX. To determine the percentage of tumors that demonstrate uptake on diagnostic 68Gallium-DOTATATE positron emission tomography (PET)/CT that would make treatment with 177Lu-DOTATATE feasible.
EXPLORATORY OBJECTIVES:
- To evaluate pituitary function in all patients to look for possible radiation late effects on the pituitary gland.
II. To estimate best biochemical response for specific tumor markers in patients with non-measurable disease.
III. To correlate biochemical response in patients with non-measurable disease with RECIST 1.1 tumor response criteria for patients with non-measurable disease.
OUTLINE:
Patients receive 177Lu-DOTATATE intravenously (IV) over 30 minutes every 8-16 weeks. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at week 72 and then every 24 weeks for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (177Lu-DOTATATE) | Experimental | Drug: Lutetium Lu 177 DotatatePatients receive 177Lu-DOTATATE IV over 30 minutes every 8-16 weeks. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histological confirmation of PHPG, MTC, parathyroid or pituitary tumor
- Locally advanced or distantly metastatic disease not amenable to surgery
- Patients should have somatostatin receptor (SSTR)+ tumor as determined by 68Ga-DOTATATE PET/CT imaging. A measurable SSTR+ tumor is defined as having greater than or equal to 10 mm in diameter with uptake higher than or equal to liver and is qualitatively higher and distinguishable from background activity
- In patients with multiple lesions (more than one) as determined by staging CT or MRI, the number of SSTR+ lesions should be more than or equal to the number of SSTR- lesions
- Patients enrolled in cohorts 1-4 should have measurable disease defined by RECIST 1.1
Key exclusion criteria (27 listed)
- Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., somatostatin analogues, cytokines or antibodies) within 12 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment. For patients with acromegaly, Cushing disease, and thyroid-stimulating hormone (TSH) secreting pituitary carcinomas treatment with somatostatin analogues is allowed
- Prior treatment with (177)Lu-DOTATATE or other radionuclide agents (e.g. (131)I meta-iodobenzylguanidine, (131)I Ultratrace Iobenguane)
- Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
- Prior treatment of any small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment
- Receipt of any other type of investigational agent within 28 days before the first dose of study treatment
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 |
|---|---|---|
| Lutetium Lu 177 DotatateAlso: 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, LutatheraGiven IV | Drug | Treatment (177Lu-DOTATATE) |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 52 weeks
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by computed tomography (CT) or magnetic resonance imaging (MRI). Will be calculated as the proportion of patients with complete responses (CR), partial responses (PR), or stable disease (SD) at the CT/MRI assessment time point.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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.
Camilo Jimenez principal investigator
M.D. Anderson Cancer Center
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 Lutetium Lu 177 Dotatate in people with Locally Advanced Adrenal Gland Pheochromocytoma and Locally Advanced Paraganglioma, run by M.D. Anderson Cancer Center 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 23 inclusion and 27 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: withdrawn, as of the sponsor's last update on 7 Sep 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective response rate (ORR) (time frame: Up to 52 weeks). 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 7 Sep 2020.