Glioblastoma MultiformePhase 1/2NCT01044966
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
A Phase 1/2 study testing ITV DepoCyt + Temozolomide in people with Glioblastoma Multiforme and Glioma, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioblastoma Multiforme, Glioma, Astrocytoma
- What is being tested?
- ITV DepoCyt + Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2014
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Patients must be at least 18 years of age but no older than 85 years.
- Diagnosis Patients with the histological diagnosis of recurrent GBM made either by biopsy or resection of recurrent disease. Cytological evidence of malignant cells in CSF and/or clinical and radiographic evidence of leptomeningeal disease are irrelevant in terms of inclusion or exclusion into this study. Bihemispheric extension ("butterfly GBM"), multi-focality, and/or subependymal spread are not contraindications to enrollment.
- Prior therapy Patients must have had an initial diagnosis of "malignant glioma" (WHO grade III or IV) and failed initial surgical resection followed by standard adjuvant therapy including external beam radiotherapy to a 2cm margin of 60 Gy, and standard temozolomide chemotherapy of 150 to 200 mg per square meter for 5 days during each 28-day cycle prior to "recurrence." Patients must not have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide prior to enrollment, not including intracavitary Gliadel wafer placement. Prior Gliadel wafer placement is not a contradiction to patient enrollment in this trial.
- Performance Status Patients must have Karnofsky performance status (KPS) of ≥ 60%.
- Recovery from Prior Therapy Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection unresponsive to treatment after 7 days). Such that they are healthy enough to safely undergo tumor biopsy and Ommaya reservoir placement. Patients must not have received any systemic therapy for recurrent disease within 3 weeks (6 weeks if a nitrosourea), or irradiation within 8 weeks prior to treatment on this study.
- Hematologic Status Patients must have a platelet count > 75,000/mm3 and ANC > 1500/mm3 within 72 hours prior to ITV DepoCyt treatment.
- Hepatic and Renal Status Patients must have adequate liver function (total bilirubin < 2.0 mg%; ALT, and AST < 4 times normal); adequate renal function (serum creatinine <1.6 mg, and BUN < 22); normal serum electrolytes (sodium, potassium, calcium, magnesium, and phosphorus).
- Informed Consent (See Appendix) All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.
Who cannot join
- Patients younger than 18 or older than 85 years of age.
- Patients with histological diagnoses other than recurrent GBM.
- Patients with a Karnofsky performance status (KPS) < 60%.
- Patients that have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide, not including intracavitary Gliadel wafer placement.
- Patients concurrently receiving other therapies (either brachytherapy or systemic) designed specifically to treat the recurrent GBM.
- Patients within 8 weeks of receiving stereotactic or external beam irradiation.
Show all 17Show fewer
- Patients with a platelet count < 75,000/mm3 and ANC < 1500/mm3 within 72 hours prior to ITV DepoCyt and/or oral temozolomide treatment.
- Patients with liver dysfunction (total bilirubin > 2.0 mg%; ALT, and AST > 4 times normal).
- Patients with renal dysfunction (serum creatinine >1.6 mg, and BUN > 22).
- Patients with abnormal serum electrolytes (sodium, potassium, calcium, magnesium, and phosphorus).
- Patients with contraindications to having placement of a ventricular access device such as Ommaya reservoir.
- Patients with clinical and/or neuroradiographic evidence of hydrocephalus or increased intracranial pressure.
- Patients with signs and symptoms of systemic infection precluding them from receiving chemotherapy or prohibiting Ommaya reservoir placement.
- Pregnant and breast feeding women will be excluded. All other women of childbearing years must have a negative serum pregnancy test.
- Patients with a ventricular-peritoneal or ventricular-atrial shunt.
- Prisoners will be excluded from this study.
- Patients or their legal guardians not willing or able to sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Phase I/II Intraventricular DepoCyt (OD # 06-2348) in Glioblastoma (76,730, 11/06)
Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround the ventricular system in patients with these aggressive tumors because it is these regions that appear to act as an incubator for future recurrences resulting in patient death. Considering the lack of significant treatment options for patients with this uniformly fatal disease, this is an important translational clinical study to perform.
Read the detailed description
Despite significant improvements in diagnostic imaging and neurosurgical techniques, the current treatment modalities for high-grade gliomas are inadequate. As such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. Fewer than 3% of GBM patients are still alive at 5 years after diagnosis. A rising incidence has been reported for GBM, and the survival rate for patients with GBM has not shown improvement in the last two decades. For this reason exploring novel therapies for the treatment of GBM is warranted.
Neuro-oncology is currently in the midst of a paradigm shift in terms of our accepted understanding of the pathophysiology of gliomagenesis. Classic "dedifferentiation" hypotheses, modeling the cellular origin of gliomas after neoplastic transformation of differentiated glia, are currently being challenged by hypotheses suggesting dysregulated glial progenitor cells are responsible for gliomagenesis. Growing evidence exists that glial progenitor cells persisting in the adult mammalian brain, lining the lateral ventricles in the subventricular zone (SVZ) and dentate gyrus, play a role in gliomagenesis. Gliomas frequently occur in close proximity to the ventricular system and SVZ with high-grade lesions like GBM "spreading" to midline structures and crossing the corpus callosum to the contralateral hemisphere. Glial progenitor cells lining the lateral ventricles in the SVZ and dentate gyrus may be the source of "tumor" cells "spreading" to midline structures such as the corpus callosum as well as continuously replenishing the tumor bed resulting in local recurrences.
The lack of significant clinical advances in treating GBM may be due to oversight of the SVZ component of this disease. It is our hypothesis that successful treatment of GBM will require suppression of the SVZ component in addition to the currently accepted modalities of hemispheric tumor resection followed by radiation and chemotherapy. This understanding of gliomagenesis has not yet been used clinically for the treatment of GBM. We hypothesize that the SVZ is the incubator for future recurrences of GBM and propose targeting SVZ progenitor cells with intraventricular liposomal encapsulated Ara-C (DepoCyt) in combination with systemic metronomic dose temozolomide. Ara-C has been previously demonstrated to inhibit the proliferation and migration of SVZ precursor cells in adult animals. Two patients treated using this novel regimen have demonstrated significant responses warranting further study of this treatment in the Phase I/II clinical trial proposed here. This has also been the basis for successful application and granting of Orphan-Drug designation for cytarabine (Ara-C) liposome injection (trade name: DepoCyt) for the treatment of gliomas (Designation # 06-2348) on January 30, 2007.
- Conditions
- Glioblastoma Multiforme, Glioma, Astrocytoma, Brain Tumor
- Being tested
- ITV DepoCyt + Temozolomide
- Keywords
- Glioblastoma, Subventricular, gliomagenesis, temozolomide, depocyt
- Medical subject headings
- Glioblastoma, Glioma, Astrocytoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITV DepoCyt + TemozolomideDrug
Also called Intrathecal liposomal Ara-C (DepoCyt), Temozolomide (Temodar)
Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous oral dosing), followed by 7 days off in a 28 day cycle as a once daily dosing regimen.
| Study group | Role | What they receive |
|---|---|---|
| ITV DepoCyt + Temozolomide | Experimental | Patients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues. Oral metronomic Temozolomide dosing of 75 mg/m2 daily for 21 days followed by 7 days off will be given throughout the Induction, Consolidation, and Maintenance Phases of the ITV DepoCyt described above. Receives: Drug: ITV DepoCyt + Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
The type and number of adverse events will be recorded and reported by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 52 weeks
Secondary outcomes (4)
Proportion of Patients With Recurrent GBM Treated With ITV DepoCyt in Combination With Oral Temozolomide Who Are Progression-free at 16 Weeks.
Eligibility of patients with GBM that are able to receive study drug to estimate the proportion of patients with recurrent GBM treated with ITV DepoCyt in combination with oral temozolomide who are progression-free at 16 weeks. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 16 weeks
Progression Free Survival
The progression free survival of patients receiving study drug will be recorded. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: At 6 months
Response Rate of Drug Treatment
Those responding to study drug will be recorded. Response will be defined as stable neurological examination in conjunction with the absence of progression as defined above.
Measured: 52 weeks
Quality of Life Outcomes Measurement
Participants recorded are those who had an improvement in QOL score, QOL outcomes will be assessed and recorded using the EORTC QLQ C30 version 3.
This 30 question questionnaire will be used to asses our patient overall feeling of well-being during the trial. Questions to assess quality of life are measured from 1-4 with the following graded values:
- Not at all
- A little
- Quite a bit
- Very much Lower total scores are consistent with better quality of life and changes of greater or equal to 10 points are considered a significant change in quality of life.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionSep 2014
Why it stopped: The study was terminated due to lack of adequate patient enrollment into trial.
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 Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce M Frankel, MD, Principal investigator, Medical University of South Carolina, Dept. of Neurosciences, Division of NeurosurgeryGustavo Leone, Study chair, Medical University of South Carolina, Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044966
- Sponsor's protocol ID
- 3542
- Other IDs
- R01FD003542-01
- Status last verified
- Jan 2019
- First submitted
- 6 Jan 2010
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Intraventricular DepoCyt (OD # 06-2348) in Glioblastoma (76,730, 11/06)
- ClinicalTrials.gov ID
- NCT01044966
- Acronym / sponsor ID
- 3542
- Conditions
- Glioblastoma Multiforme, Glioma, Astrocytoma, Brain Tumor
- Keywords
- Glioblastoma, Subventricular, gliomagenesis, temozolomide, depocyt
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to lack of adequate patient enrollment into trial.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current treatments for Glioblastoma Multiforme (GBM), the most common and malignant primary brain tumor are inadequate and as such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. This study aims to develop a new treatment for GBM by suppressing glial progenitor cells that surround the ventricular system in patients with these aggressive tumors because it is these regions that appear to act as an incubator for future recurrences resulting in patient death. Considering the lack of significant treatment options for patients with this uniformly fatal disease, this is an important translational clinical study to perform.
Detailed description
Despite significant improvements in diagnostic imaging and neurosurgical techniques, the current treatment modalities for high-grade gliomas are inadequate. As such, the median survival for most patients with GBM is on the order of months, even after cytoreductive surgery, radiation and chemotherapy. Fewer than 3% of GBM patients are still alive at 5 years after diagnosis. A rising incidence has been reported for GBM, and the survival rate for patients with GBM has not shown improvement in the last two decades. For this reason exploring novel therapies for the treatment of GBM is warranted.
Neuro-oncology is currently in the midst of a paradigm shift in terms of our accepted understanding of the pathophysiology of gliomagenesis. Classic "dedifferentiation" hypotheses, modeling the cellular origin of gliomas after neoplastic transformation of differentiated glia, are currently being challenged by hypotheses suggesting dysregulated glial progenitor cells are responsible for gliomagenesis. Growing evidence exists that glial progenitor cells persisting in the adult mammalian brain, lining the lateral ventricles in the subventricular zone (SVZ) and dentate gyrus, play a role in gliomagenesis. Gliomas frequently occur in close proximity to the ventricular system and SVZ with high-grade lesions like GBM "spreading" to midline structures and crossing the corpus callosum to the contralateral hemisphere. Glial progenitor cells lining the lateral ventricles in the SVZ and dentate gyrus may be the source of "tumor" cells "spreading" to midline structures such as the corpus callosum as well as continuously replenishing the tumor bed resulting in local recurrences.
The lack of significant clinical advances in treating GBM may be due to oversight of the SVZ component of this disease. It is our hypothesis that successful treatment of GBM will require suppression of the SVZ component in addition to the currently accepted modalities of hemispheric tumor resection followed by radiation and chemotherapy. This understanding of gliomagenesis has not yet been used clinically for the treatment of GBM. We hypothesize that the SVZ is the incubator for future recurrences of GBM and propose targeting SVZ progenitor cells with intraventricular liposomal encapsulated Ara-C (DepoCyt) in combination with systemic metronomic dose temozolomide. Ara-C has been previously demonstrated to inhibit the proliferation and migration of SVZ precursor cells in adult animals. Two patients treated using this novel regimen have demonstrated significant responses warranting further study of this treatment in the Phase I/II clinical trial proposed here. This has also been the basis for successful application and granting of Orphan-Drug designation for cytarabine (Ara-C) liposome injection (trade name: DepoCyt) for the treatment of gliomas (Designation # 06-2348) on January 30, 2007.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITV DepoCyt + Temozolomide | Experimental | Drug: ITV DepoCyt + TemozolomidePatients will undergo an induction phase of intraventricular (ITV) DepoCyt, using the dosage determined from the Phase I portionPatients with stable disease (clinically and radiographically), not exhibiting systemic toxicity, will undergo a three month consolidation phase of ITV DepoCyt, for one month (Cycles 3-6). Patients without progression or toxicity will undergo maintenance therapy using ITV DepoCyt every four weeks (+/- 3 days) for a maximum of 8 months (cycles 7-14) or until recurrence or toxicity ensues. Oral metronomic Temozolomide dosing of 75 mg/m2 daily for 21 days followed by 7 days off will be given throughout the Induction, Consolidation, and Maintenance Phases of the ITV DepoCyt described above. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age Patients must be at least 18 years of age but no older than 85 years.
- Diagnosis Patients with the histological diagnosis of recurrent GBM made either by biopsy or resection of recurrent disease. Cytological evidence of malignant cells in CSF and/or clinical and radiographic evidence of leptomeningeal disease are irrelevant in terms of inclusion or exclusion into this study. Bihemispheric extension ("butterfly GBM"), multi-focality, and/or subependymal spread are not contraindications to enrollment.
- Prior therapy Patients must have had an initial diagnosis of "malignant glioma" (WHO grade III or IV) and failed initial surgical resection followed by standard adjuvant therapy including external beam radiotherapy to a 2cm margin of 60 Gy, and standard temozolomide chemotherapy of 150 to 200 mg per square meter for 5 days during each 28-day cycle prior to "recurrence." Patients must not have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide prior to enrollment, not including intracavitary Gliadel wafer placement. Prior Gliadel wafer placement is not a contradiction to patient enrollment in this trial.
- Performance Status Patients must have Karnofsky performance status (KPS) of ≥ 60%.
- Recovery from Prior Therapy Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, prior to entering this study and must be without significant systemic illness (e.g. infection unresponsive to treatment after 7 days). Such that they are healthy enough to safely undergo tumor biopsy and Ommaya reservoir placement. Patients must not have received any systemic therapy for recurrent disease within 3 weeks (6 weeks if a nitrosourea), or irradiation within 8 weeks prior to treatment on this study.
Key exclusion criteria (17 listed)
- Patients younger than 18 or older than 85 years of age.
- Patients with histological diagnoses other than recurrent GBM.
- Patients with a Karnofsky performance status (KPS) < 60%.
- Patients that have received more than one other systemic or ITV adjuvant chemotherapy regimen in addition to temozolomide, not including intracavitary Gliadel wafer placement.
- Patients concurrently receiving other therapies (either brachytherapy or systemic) designed specifically to treat the recurrent GBM.
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 |
|---|---|---|
| ITV DepoCyt + TemozolomideAlso: Intrathecal liposomal Ara-C (DepoCyt), Temozolomide (Temodar)Intrathecal liposomal Ara-C dosing will begin at 50 mg ITV every 2-4 weeks, and de-escalated based on toxicity obtained from the Phase I portion of the trial. Metronomic dosing of temozolomide will be given at 75 mg/m2 for 21 days (continuous oral dosing), followed by 7 days off in a 28 day cycle as a once daily dosing regimen. | Drug | ITV DepoCyt + Temozolomide |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 52 weeks
The type and number of adverse events will be recorded and reported by the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
4 secondary outcomes
Proportion of Patients With Recurrent GBM Treated With ITV DepoCyt in Combination With Oral Temozolomide Who Are Progression-free at 16 Weeks.
Time frame: 16 weeks
Progression Free Survival
Time frame: At 6 months
Response Rate of Drug Treatment
Time frame: 52 weeks
Quality of Life Outcomes Measurement
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- (Link to contact Dr. Frankel at Medical University of South Carolina)Link 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.
Bruce M Frankel, MD principal investigator
Medical University of South Carolina, Dept. of Neurosciences, Division of Neurosurgery
Gustavo Leone study chair
Medical University of South Carolina, Hollings 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 1/2 study testing ITV DepoCyt + Temozolomide in people with Glioblastoma Multiforme and Glioma, run by Medical University of South Carolina 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 12 Feb 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 12 Feb 2019). 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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: 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 12 Feb 2019.