Malignant GliomaPhase 2NCT00953121
Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG)
A Phase 2 study testing bevacizumab and CPT-11 and Carboplatin in people with Malignant Glioma, run by Annick Desjardins at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Bevacizumab, CPT-11 and Carboplatin in combination are effective in the treatment of recurrent malignant glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- bevacizumab and CPT-11 and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohorts A and B only
- No prior failure or grade ≥ 3 toxicity to bevacizumab, irinotecan or carboplatin.
- Cohort C only
- Failure on prior bevacizumab therapy
- No prior failure or grade ≥ 3 toxicity to either irinotecan or carboplatin.
- All Cohorts
Show all 18Show fewer
- Age * 18 years
- Karnofsky Performance Status (KPS) ≥ 70%
- No more than 3 prior episodes of disease progression
- An interval of at least 4 weeks between prior surgical resection or one week from stereotactic biopsy
- An interval of at least 12 weeks from the end of prior radiotherapy unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there are progressive changes on MRI on at least two consecutive MRI scans at least four weeks apart, or there is biopsy-proven tumor progression
- An interval of at least 4 weeks from prior chemotherapy (6 weeks for nitrosoureas) or investigational agent unless the patient has recovered from all anticipated toxicities associated with that therapy
- Hematocrit ≥ 29%, absolute neutrophil count (ANC) ≥ 1,000 cells/*l, platelets ≥ 100,000 cells/*l
- Serum creatinine ≤ 1.5 times upper limit of normal, serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 times upper limit of normal and bilirubin ≤ 2.0 times upper limit of normal
- International Normalized Ratio (INR) < 1.5 or prothrombin time/partial thromboplastin time (PT/PTT) within 1.5 time upper limit of normal (ULN).
- Signed informed consent approved by the Institutional Review Board prior to patient entry
- No evidence of hemorrhage on the baseline MRI or CT scan other than those that are stable grade 1
- If sexually active, patients will take contraceptive measures for the duration of the treatments. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation, hysterectomy, vasectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD)
Who cannot join
- Disease-Specific Exclusions
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
- Active infection requiring intravenous antibiotics
- Requires therapeutic anti-coagulation with warfarin
- General Medical Exclusions
- Subjects meeting any of the following criteria are ineligible for study entry:
Show all 28Show fewer
- Inability to comply with study and/or follow-up procedures
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- Severe hepatic insufficiency (ongoing grade 3 or greater hepatic adverse events) or known active chronic hepatitis
- Homozygosity for the *28 uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) allele.
- Bevacizumab-Specific Exclusions
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either:
- Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
- Known hypersensitivity to any component of bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanized antibodies."
- Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Phase II Study of Bevacizumab Plus Irinotecan and Carboplatin for Recurrent Malignant Glioma Patients
The purpose of this study is to determine whether Bevacizumab, CPT-11 and Carboplatin in combination are effective in the treatment of recurrent malignant glioma.
Read the detailed description
Three cohorts will accrue and will be assessed independently. Each cohort will evaluate a separate malignant glioma subpopulation. Cohort A will assess recurrent glioblastoma multiforme (GBM) subjects who have not previously failed either bevacizumab, irinotecan or carboplatin. Cohort B will assess recurrent grade 3 malignant glioma subjects who have not previously failed either bevacizumab, irinotecan or carboplatin. Cohort C will assess recurrent GBM subjects who have failed prior bevacizumab therapy but who have not failed prior irinotecan or carboplatin. The primary endpoint of each cohort will be 6-month progression-free survival. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at Duke.
For each cohort, bevacizumab will be administered at 10 mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for subjects not on Cytochrome P450, family 3, subfamily A (CYP3A)-inducing anti-epileptics (EIAEDs) and 340 mg/m2 for subjects on EIAEDs. All subjects will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4.
Within 2 weeks of starting the study, subject's medical history and current medical conditions will be recorded. A physical examination including vital signs (temperature, respiratory rate, blood pressure, and pulse), height and weight, and neurological examination will be done. Subject will be asked about his or her ability to perform everyday tasks. Blood tests for assessment of a complete blood count including monitoring liver and kidney function and a urine test to check kidney function will be performed. For women of childbearing potential, a blood test to rule out pregnancy will be done prior to the start of treatment. Blood tests will also check for a specific gene, which may affect how much irinotecan subject is given. A magnetic resonance imaging (MRI) of will be performed within 2 weeks before starting study drugs as well as after every eight weeks to determine response and progression.
In total, approximately 3 teaspoons (15 mL) of blood will be drawn for the evaluations before starting study drug. These tests will be repeated every 8 weeks (blood chemistries), except a complete blood count (approximately 1 teaspoon), which will need to be repeated every week as well as when it is deemed clinically necessary to repeat. Every 4 weeks a urine test will be performed to test the amount of protein in subject's urine.
Placement of a central venous line may be required. Subjects will be seen in the clinic for a physical and neurological examination every four (4) weeks. Urine and blood laboratory tests will also be obtained at these visits. In addition, a complete blood count (about 1 teaspoon) will be obtained every week. Blood pressure measurement will be required every 2 weeks. MRI (Magnetic Resonance Imaging) scans will be done every 8 weeks (after every 2 cycles) to determine the effectiveness of the study drugs. If the tumor remains the same size or smaller, subject will continue to receive study drugs for 12 cycles unless there are bad side effects or unless there is evidence that the drug is not working. If evaluations show that there may be persistent tumor after 12 cycles, subject may continue treatment. Study drugs will stop if the subject's tumor gets larger.
Additional tests may be done at the discretion of the doctor as part of regular care throughout the study. These exams and tests will be done to monitor the effects of the study interventions.
- Conditions
- Malignant Glioma
- Being tested
- bevacizumab and CPT-11 and Carboplatin
- Keywords
- irinotecan, carboplatin, bevacizumab, Avastin
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab and CPT-11 and CarboplatinDrug
Also called bevacizumab, Avastin, Irinotecan, CPT-11
Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A-Grade IV No Failure | Experimental | Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin Receives: Drug: bevacizumab and CPT-11 and Carboplatin |
| Cohort B-Grade III No Failure | Experimental | Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin Receives: Drug: bevacizumab and CPT-11 and Carboplatin |
| Cohort C-Failed Prior Therapy | Experimental | Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies Receives: Drug: bevacizumab and CPT-11 and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Progression-free Survival
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.
Measured: 6 months
Secondary outcomes (4)
Objective Response Rate
Percentage of participants with an objective response (complete response or partial response) based on Response Assessment in Neuro-Oncology (RANO) criteria. A complete response is defined as disappearance of all enhancing tumor on contrast enhanced MRI scan. Patient must be off steroids or only on adrenal maintenance doses. A partial response is defined as greater than or equal to a 50% reduction in the size (products of the largest perpendicular diameters) for all enhancing lesions. No new lesions may arise. Steroids must be stable or decreasing dose.
Measured: 34 months
Median Progression Free Survival (PFS)
Time in months from the start of study treatment to the date of first progression according to RANO criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Measured: 40 months
Median Overall Survival (OS)
Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Measured: 40 months
Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin
Number of patients experiencing a toxicity greater than or equal to grade 2 treatment-related toxicity
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJan 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annick Desjardins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Annick Desjardins, Duke University
- Investigators
- Annick Desjardins, MD, FRCPC, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953121
- Sponsor's protocol ID
- Pro00016712
- Status last verified
- Sep 2013
- First submitted
- 4 Aug 2009
- Last updated
- 16 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reardon DA, Desjardins A, Peters KB, Gururangan S, Sampson JH, McLendon RE, Herndon JE 2nd, Bulusu A, Threatt S, Friedman AH, Vredenburgh JJ, Friedman HS. Phase II study of carboplatin, irinotecan, and bevacizumab for bevacizumab naive, recurrent glioblastoma. J Neurooncol. 2012 Mar;107(1):155-64. doi: 10.1007/s11060-011-0722-2. Epub 2011 Oct 11.
PubMed 21986722
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bevacizumab Plus Irinotecan and Carboplatin for Recurrent Malignant Glioma Patients
- ClinicalTrials.gov ID
- NCT00953121
- Acronym / sponsor ID
- Pro00016712
- Conditions
- Malignant Glioma
- Keywords
- irinotecan, carboplatin, bevacizumab, Avastin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Annick DesjardinsUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 4 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Bevacizumab, CPT-11 and Carboplatin in combination are effective in the treatment of recurrent malignant glioma.
Detailed description
Three cohorts will accrue and will be assessed independently. Each cohort will evaluate a separate malignant glioma subpopulation. Cohort A will assess recurrent glioblastoma multiforme (GBM) subjects who have not previously failed either bevacizumab, irinotecan or carboplatin. Cohort B will assess recurrent grade 3 malignant glioma subjects who have not previously failed either bevacizumab, irinotecan or carboplatin. Cohort C will assess recurrent GBM subjects who have failed prior bevacizumab therapy but who have not failed prior irinotecan or carboplatin. The primary endpoint of each cohort will be 6-month progression-free survival. This study will be conducted at The Preston Robert Tisch Brain Tumor Center at Duke.
For each cohort, bevacizumab will be administered at 10 mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for subjects not on Cytochrome P450, family 3, subfamily A (CYP3A)-inducing anti-epileptics (EIAEDs) and 340 mg/m2 for subjects on EIAEDs. All subjects will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4.
Within 2 weeks of starting the study, subject's medical history and current medical conditions will be recorded. A physical examination including vital signs (temperature, respiratory rate, blood pressure, and pulse), height and weight, and neurological examination will be done. Subject will be asked about his or her ability to perform everyday tasks. Blood tests for assessment of a complete blood count including monitoring liver and kidney function and a urine test to check kidney function will be performed. For women of childbearing potential, a blood test to rule out pregnancy will be done prior to the start of treatment. Blood tests will also check for a specific gene, which may affect how much irinotecan subject is given. A magnetic resonance imaging (MRI) of will be performed within 2 weeks before starting study drugs as well as after every eight weeks to determine response and progression.
In total, approximately 3 teaspoons (15 mL) of blood will be drawn for the evaluations before starting study drug. These tests will be repeated every 8 weeks (blood chemistries), except a complete blood count (approximately 1 teaspoon), which will need to be repeated every week as well as when it is deemed clinically necessary to repeat. Every 4 weeks a urine test will be performed to test the amount of protein in subject's urine.
Placement of a central venous line may be required. Subjects will be seen in the clinic for a physical and neurological examination every four (4) weeks. Urine and blood laboratory tests will also be obtained at these visits. In addition, a complete blood count (about 1 teaspoon) will be obtained every week. Blood pressure measurement will be required every 2 weeks. MRI (Magnetic Resonance Imaging) scans will be done every 8 weeks (after every 2 cycles) to determine the effectiveness of the study drugs. If the tumor remains the same size or smaller, subject will continue to receive study drugs for 12 cycles unless there are bad side effects or unless there is evidence that the drug is not working. If evaluations show that there may be persistent tumor after 12 cycles, subject may continue treatment. Study drugs will stop if the subject's tumor gets larger.
Additional tests may be done at the discretion of the doctor as part of regular care throughout the study. These exams and tests will be done to monitor the effects of the study interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A-Grade IV No Failure | Experimental | Drug: bevacizumab and CPT-11 and CarboplatinRecurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin |
| Cohort B-Grade III No Failure | Experimental | Drug: bevacizumab and CPT-11 and CarboplatinRecurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin |
| Cohort C-Failed Prior Therapy | Experimental | Drug: bevacizumab and CPT-11 and CarboplatinRecurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Cohorts A and B only
- No prior failure or grade ≥ 3 toxicity to bevacizumab, irinotecan or carboplatin.
- Cohort C only
- Failure on prior bevacizumab therapy
- No prior failure or grade ≥ 3 toxicity to either irinotecan or carboplatin.
Key exclusion criteria (28 listed)
- Disease-Specific Exclusions
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
- Active infection requiring intravenous antibiotics
- Requires therapeutic anti-coagulation with warfarin
- General Medical Exclusions
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 |
|---|---|---|
| bevacizumab and CPT-11 and CarboplatinAlso: bevacizumab, Avastin, Irinotecan, CPT-11Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4. | Drug | Cohort A-Grade IV No Failure, Cohort B-Grade III No Failure, Cohort C-Failed Prior Therapy |
Primary outcome
6 Month Progression-free Survival
Time frame: 6 months
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Response Assessment in Neuro-Oncology (RANO) criteria, or to death due to any cause. Progression is defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. Patients may also be classified as progressive disease with significant neurologic decline felt to be due to underlying tumor and not attributable to co-morbid event or concurrent medication regardless of MRI findings.
4 secondary outcomes
Objective Response Rate
Time frame: 34 months
Median Progression Free Survival (PFS)
Time frame: 40 months
Median Overall Survival (OS)
Time frame: 40 months
Safety of Bevacizumab (Avastin) in Combination With Irinotecan and Carboplatin
Time frame: 34 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21986722Reardon DA, Desjardins A, Peters KB, Gururangan S, Sampson JH, McLendon RE, Herndon JE 2nd, Bulusu A, Threatt S, Friedman AH, Vredenburgh JJ, Friedman HS. Phase II study of carboplatin, irinotecan, and bevacizumab for bevacizumab naive, recurrent glioblastoma. J Neurooncol. 2012 Mar;107(1):155-64. doi: 10.1007/s11060-011-0722-2. Epub 2011 Oct 11.
- The Preston Robert Tisch Brain Tumor Center at DUKELink provided by the sponsor.
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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.
Annick Desjardins, MD, FRCPC principal investigator
Duke University
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 bevacizumab and CPT-11 and Carboplatin in people with Malignant Glioma, run by Annick Desjardins 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 18 inclusion and 28 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 16 Sep 2013. 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 4 Sep 2013). 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?
6 Month Progression-free Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953121, which also lists 1 linked publication.
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 16 Sep 2013.